requested document(s) erica.staab@henryscheincs/2gl ea pk/50 bx/50 1envlp bx/50 ea ea 100/bx 12/pk...

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[email protected] Requested Document(s) Attn: . From: . Comments: LINES 152-175 ITEM CODE DESCRIPTION SIZE STRENGTH SCH0232 SCH0686 SCH0870 SCH1640 SCH2310 SCH4954 SCH6107 SCH8386 SCH8582 SCH8969 SCK1800 SCK3756 SCK3906 SCL1637 1001071 1025425 1027377 1126770 1126785 1950444 1955075 3336180 3783216 5830036 ADHESIVE PERMALASTIC DYCAL COMPLETE DENTIN PKG ARTIC PAPER THIN BLUE MOUTH PROPS SM CHILD BLK MAXICIDE PLUS PEROXIDE JET REPAIR ACRYLIC LIQ OD LISTERINE COOL MINT OD ALUWAX DENTURE MEPIVACAINE 3% PLAIN C-W LIDOCAINE 2% 1:100 GELFOAM DENTAL PAK SZ4 SEPTOCAINE CART 4% W/EPI EQUIA FORTE INTRO A2 SQ DENTIN BONDING AGENT SQ CRITERION LP LATEX GLOVE DENTURE BOXES MASTER HP LUBRICANT OIL CRITERION NITRILE EC GLOV BEAUTIFIL II SYRINGE 4.5G GLASIONOMER BASE CEMENT MIRACLE MIX POWDER FS HEMOSTATIC LIQUID 60CC POLIDENT TABLETS 3-MINUTE EACH EA BX/12BKS BX/2 GAL PT 4OZ CS/2GL EA PK/50 BX/50 1ENVLP BX/50 EA EA 100/BX 12/PK EA 50/BX EA EA 15GM/BT EA 12/CA 1 OZ 1002876 PVT LBL PVT LBL PVT LBL PVT LBL 1:100M KIT X-SMALL ASSORT .25OZBT X-SMALL B1 YELLOW 2OZ 40CT

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Page 1: Requested Document(s) ERICA.STAAB@HENRYSCHEINCS/2GL EA PK/50 BX/50 1ENVLP BX/50 EA EA 100/BX 12/PK EA 50/BX EA EA 15GM/BT EA 12/CA 1 OZ 1002876 PVT LBL PVT LBL PVT LBL PVT LBL 1:100M

[email protected] Document(s)

Attn: .

From: .

Comments: LINES 152-175

ITEM CODE DESCRIPTION SIZE STRENGTH

SCH0232SCH0686SCH0870SCH1640SCH2310SCH4954SCH6107SCH8386SCH8582SCH8969SCK1800SCK3756SCK3906SCL16371001071102542510273771126770112678519504441955075333618037832165830036

ADHESIVE PERMALASTIC DYCAL COMPLETE DENTIN PKGARTIC PAPER THIN BLUE MOUTH PROPS SM CHILD BLK MAXICIDE PLUS PEROXIDE JET REPAIR ACRYLIC LIQ ODLISTERINE COOL MINT OD ALUWAX DENTURE MEPIVACAINE 3% PLAIN C-W LIDOCAINE 2% 1:100 GELFOAM DENTAL PAK SZ4 SEPTOCAINE CART 4% W/EPI EQUIA FORTE INTRO A2 SQDENTIN BONDING AGENT SQCRITERION LP LATEX GLOVE DENTURE BOXES MASTER HP LUBRICANT OIL CRITERION NITRILE EC GLOVBEAUTIFIL II SYRINGE 4.5GGLASIONOMER BASE CEMENT MIRACLE MIX POWDER FS HEMOSTATIC LIQUID 60CCPOLIDENT TABLETS 3-MINUTE

EACH EABX/12BKSBX/2 GAL PT 4OZCS/2GLEAPK/50 BX/501ENVLPBX/50 EAEA 100/BX 12/PK EA 50/BX EA EA 15GM/BTEA 12/CA

1 OZ

1002876PVT LBLPVT LBLPVT LBL

PVT LBL

1:100M

KITX-SMALLASSORT.25OZBTX-SMALLB1YELLOW

2OZ40CT

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DENTSPLY/International DENTSPLY/Caulk Safety Data Sheet 523899

1. Identification

Product Name DYCAL Radiopaque Calcium Hydroxide Composition

SDS Code Number 523899

Substance Identity

DYCAL Radiopaque Calcium Hydroxide Composition Date of Last Revision 02/21/14

Manufacturer: DENTSPLY Caulk

Address 38 West Clarke Avenue Milford DE 19963-1805 http://www.caulk.com http://www.dentsply.com

Grades or Minor Variant Identities Not Applicable

Information Telephone Number (302) 422-4511 (8:00 AM 4:30 PM Eastern Time)

Product Use (for Canada) Not Applicable

Emergency Telephone Number (302) 422-4511 (8:00 AM 4:30 PM Eastern Time)

2. Hazard(s) Identification

WARNING CAUSES SKIN IRRITATION

Wash hands thoroughly after handling.

Wear protective gloves. IF ON SKIN: Wash with plenty of soap and water.

I f skin ir r itation occurs: Get medical advice/ attention. Take off contaminated clothing and wash before reuse.

3. Composition/Information on Ingredients - Base Paste Hazardous Components C.A.S. Number Exposure Limits % Calcium Tungstate 7790-75-2 5 mg/M3 < than 20 Zinc Oxide 1314-13-2 10 mg/M3 < than 15 Disalicylate ester of 1,3 butylene glycol 73240-13-8 Not Established < than 50 Other Information: Colorants are synthetic inorganic iron oxides.

3. Composition/Information on Ingredients - Catalyst Paste Hazardous Components C.A.S. Number Exposure Limits % Calcium Hydroxide 1305-62-0 5 mg/M3 < than 55 Zinc Oxide 1314-13-2 10 mg/M3 < than 15 Titanium Dioxide 13463-67-7 10 mg/M3 < than 10

3. Hazard Identification Emergency Overview: Material is an irritant. Routes of Exposure

Signs and Symptoms

Single, Repeated, or Lifetime Exposure

Severity (M ild, Moderate, Severe)

Acute and Chronic Health Effect(s)

Target Organ(s)

Eye Material may cause irritation. Single & Repeated Moderate Irritation and possible corneal damage due to the caustic nature of ingredient used in the product.

Not Applicable

Skin Material may cause irritation. Single & Repeated Mild Irritation or possible allergic response.

Not Applicable

Inhalation Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Ingestion Material may cause irritation. Not Applicable M ild Irritation due to the caustic

nature of ingredients used in the product.

Not Applicable

Other Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Medical Conditions Aggravated by Exposure Open sores and wounds of the skin. Carcinogenicity NTP?: Not listed IARC monographs?: Not listed OSHA regulated?: No All components of this product are in compliance with the inventory listing Requirements of the U. S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory.

~Verified on 2014-06 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-06. ~

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Potential Environmental Effects Do not allow to enter sewers/ surface or ground water. NFPA Hazard Classification Ratings (Scale 0-4), Health = 1, Fire = 0, Reactivity = 0

4. First Aid Measures Routes of Exposure

First Aid Instructions Immediate Medical Attention

Delayed Effects

Eye Rinse opened eye for several minutes under running water. If symptoms persist consult physician.

Not Applicable Not Applicable

Skin Immediately wash with soap and water and rinse thoroughly. Not Applicable Not Applicable Inhalation Supply fresh air, If symptoms persist consult physician.

This may not be of concern when using clinically relevant quantities. Not Applicable Not Applicable

Ingestion Rinse out mouth and then drink plenty of water. Consult a physician immediately.

This may not be of concern when using clinically relevant quantities.

Not Applicable Not Applicable

Other Not Applicable Not Applicable Not Applicable Note to Physicians (Treating, Testing and Monitoring): Treat symptomatically.

5. Fire and Explosion Data Flashpoint Method: Not Applicable Flammable (Explosive) Limits in Air

LEL: Not Applicable UEL: Not Applicable Autoignition Temperature: Not Applicable

Other: Not Applicable

Flame Propagation or Burning Rate (for Solids): Not Applicable

Properties Contributing to Fire Intensity: Not Applicable Flammability Classification: Not Applicable

Extinguishing Media: Use fire extinguishing methods suitable to surrounding conditions. Extinguishing Media to Avoid: Not Applicable Protection and Procedures for Firefighters: Firefighters should wear self -contained respiratory protective devices. Unusual Fire and Explosion Hazards: Formation of toxic gases is possible during heating or in case of fire.

6. Accidental Release Measures Containment Techniques: Material is a high viscosity paste, but will flow somewhat. Spill/Leak Clean-up Procedures and Equipment: Absorb with liquid binding material (sand, vermiculite, diatomite, acid binders, universal binders or sawdust). Scoop up bulk material and place in a labeled plastic or metal container. Evacuation Procedures: Not Applicable Special Instructions: Not Applicable Reporting Requirements: Not Applicable

7. Handling and Storage Handling Practices and Warnings: Product is intended for dental use only. Handling of this product should be by trained dental healthcare professionals only. Observe normal care for working with chemicals. Storage Practices and Warnings: Store only in the original package. Keep package tightly sealed. Store in a dry area. Store away from food and beverages.

8. Exposure Control / Personal Protection

Individual Protection Measures

Personal Protective Equipment for Normal Use Personal Protective Equipment for Emergencies

Eye/Face Safety Glasses Not Applicable Skin The glove material has to be impermeable and resistant to the product. Not Applicable

Inhalation Not Required. This may not be of concern when using clinically relevant quantities. Not Applicable Body Protection Protective work clothing Not Applicable

Occupational Exposure Limits: Not Applicable Engineering Controls: Not Applicable

9. Physical and Chemical Character istics Appearance: Base-light yellow colored paste, catalyst-white paste. Odor: Base odor of cloves, Catalyst Odorless. Normal Physical State: Paste Melting Point: Not Applicable Specific Gravity: Base 2.0 g/cm3 Catalyst 1.8 g/cm3 Solubili ty in Water: Not soluble pH: Base-Not Applicable, Catalyst- 11.5 Vapor Pressure (mm Hg): Not Applicable Vapor Density (AIR=1): Not Applicable Evaporation Rate (Butyl Acetate =1): Not Applicable Flashpoint - Method: Not Applicable Flammable (Explosive) Limits in Air

LEL: Not Applicable UEL: Not Applicable Autoignition Temperature: Not Applicable

Other: Not Applicable

10. Stability and Reactivity Data Incompatibili ty (Materials to Avoid): Not Applicable Hazardous Products Produced During Decomposition: Not Applicable Hazardous Polymerization: May Occur May Not Occur Conditions to Avoid: None known Stabili ty? Stable Unstable Conditions to Avoid: None known

11.Toxicological Information Toxicity Data, Epidemiology Studies, Carcinogenicity, Neurological Effects, Genetic Effects, Reproductive Effects, or Structure Activity Data:

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Irritating to skin and mucous membranes. Emergency Overview: Material is an irritant.

Routes of Exposure

Signs and Symptoms

Single, Repeated, or Lifetime Exposure

Severity (M ild, Moderate, Severe)

Acute and Chronic Health Effect(s)

Target Organ(s)

Eye Material may cause irritation. Single & Repeated Moderate Irritation and possible corneal damage due to the caustic nature of ingredient used in the product.

Not Applicable

Skin Material may cause irritation. Single & Repeated Mild Irritation or possible allergic response.

Not Applicable

Inhalation Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Ingestion Material may cause irritation. Not Applicable M ild Irritation due to the caustic nature

of ingredients used in the product. Not Applicable

Other Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable Medical Conditions Aggravated by Exposure Open sores and wounds of the skin. Carcinogenicity NTP?: Not listed IARC monographs?: Not listed OSHA regulated?: No All components of this product are in compliance with the inventory listing Requirements of the U. S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory. Potential Environmental Effects: Potential Environmental Effects Do not allow to enter sewers/ surface or ground water. NFPA Hazard Classification Ratings (Scale 0-4), Health = 1, Fire = 0, Reactivity = 0

12.Ecological Information Toxicity Data, Environmental Fate, Physical/Chemical Data, or other Data Supporting Environmental Hazard Statements: Water Hazard class1 (Self-assessment): slightly hazardous for water. Do not allow undiluted product or large quantities of it to reach ground water, water streams or sewage system. Toxic to fish. Also poisonous for fish and plankton in water bodies. Toxic for aquatic organisms.

Danger

Hazardous to aquatic l ife 13.Disposal Considerations

Regulations: Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Dispose of material as solid waste in a closed container. Dispose of in accordance with Federal, State and Local regulations Properties (Physical/Chemical) Affecting Disposal: Dispose of material as solid waste in a closed container.

14.Transport Information Regulated for Shipping: No. Not Regulated DOT Shipping Name: Not Regulated Packing Group: Not Applicable Do Changes in Quantities, packaging, or shipment method change product classif ication? No

DOT Hazard Class: Not Applicable UN Number: Not Applicable

15.Regulatory Information This product has been classified in accordance with the hazard criteria of the Globally Harmonized System of Classification and Labeling of Chemicals and the SDS contains all of the information required by the Canadian Controlled Products Regulations. U.S. Federal Regulations: CERCLA 103 Reportable Quantity: This product is not subject to CERCLA reporting requirements. Many states have more stringent release reporting requirements. Report spills required under federal, state and local regulations Section 313 Toxic Chemicals: This product contains the following chemicals subject to Annual Release Reporting Requirements Under SARA Title III, Section 313 (40 CFR 372): None Section 302 Extremely Hazardous Substances (TPQ): None EPA Toxic Substances Control Act (TSCA) Status: All of the components of this product are listed on the TSCA inventory. U.S. State Regulations California Proposition 65: This product does not contain any chemicals, which are on the California Proposition 65 list. International Regulations: Canadian Environmental Protection Act: This product is a medical device and not subject to chemical notification requirements. European Community Labeling: Not a dangerous preparation. These R and S phrases apply to base and catalyst: R36/38 Irritating to eyes and skin. R51/53 Toxic to aquatic organisms, may cause long-term effects in the environment. S26 Incase of contact with eyes, rinse immediately with plenty of water and seek medical advice. S28 After contact with skin, wash immediately with plenty of water. S37 Wear suitable gloves. S57 Use appropriate container to avoid environmental contamination. S60 This material and its container must be disposed of as hazardous waste. These R and S phrases apply to catalyst: R41 Risk of serious damage to eyes. R50/53 Very toxic to aquatic organisms, may cause long-term effects in the environment. S24 Avoid contact with skin. European Inventory of New and Existing Chemicals Substances (EINECS): This product is a medical device and not subject to chemical notification requirements. Other: Not Applicable

16.Other Information To the best of our knowledge this product does not contain gluten, wheat grains, flaxseed, natural rubber, or natural latex. All components are synthetically produced; none are derived from animal products. This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific products features and shall not establish a legally valid contractual relationship. The attached safety data sheet covers the dangers and measures to be taken when large quantities of material are released, for example due to accidents during transport or storage by the dealer. For quantities of material typically used in clinical practice, information necessary for safe use and storage of the product is given in the DFU.

~Verified on 2014-06 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-06. ~

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Safety Data Sheet

Section 1: Identification

Product Name: Articulating Paper Distributor: Henry Schein, Inc., 135 Duryea Road, Melville, NY 11747 Telephone: 1-800-472-4346 Emergency Information: USA Chemtrec: 1-800-424-9300 or 703-527-3887 Date Prepared: June 30, 2014

Section 2: Hazard(s) Identification

Physical Hazards: None Health Hazards: None Hazardous Ingredients: Principal Components N/A Percent N/A OSHA PEL N/A

Section 3: Composit ion/ I nformation on Ingredients

Physical Data Specific Gravity N/A Melting Point 180 Degrees Fahrenheit Boiling Point N/A Solubility in Water Insoluble Appearance and Odor Waxy Coated Paper, Mild Odor **This product does not contain Peanut Oil in the Formulation

Section 4: First-Aid Measures

Skin Wash Off with Soap and Water Eyes Flush with Water Ingestion Get Medical Advice Health Hazard Assessment Threshold Limits N/A Primary Routes of Exposure Skin Contact or Ingestion Effects of Overexposure None Known

Section 5: Fire-Fighting Measures

Flash Point N/A Extinguishing Media Water, Fog, Foam, Carbon Dioxide, Dry Chemical, Halon Special Fire Fighting Protective Equipment Self Contained Breathing Apparatus with Full Face Piece And Protective Clothing Unusual Fire and Explosion Hazards None Known

~Verified on 2014-07 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-07. ~

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Section 6: Accidental Release Measures

Spills or Leaks N/A Disposal Method Material is not regulated and can be disposed of with normal office waste

Section 7: Handling and Storage

N/A

Section 8: Exposure Controls/Personal Protection

Respiratory Protection None when used as intended Ventilation General office conditions Protective Clothing None when used as intended Eye Protection None when used as intended Other Protection Equipment None when used as intended OSHA PEL N/A

Section 9: Physical and Chemical Propert ies

N/A

Section 10: Stability and Reactivity

Stability Stable Incompatibility N/A Hazardous Polymerization Will Not Occur Hazardous Decomposition N/A

Section 11: Toxicological Information

CERCLA and SARA Regulations Contains no know toxic chemicals subject to reporting Requirements California Prop. 65 No Toxic Material to Report

Section 12: Ecological Information* (non-mandatory)

Not mandatory but keep section in document and leave empty/blank

Section 13: Disposal Considerations* (non-mandatory)

Not mandatory but keep section in document and leave empty/blank

Section 14: Transport Information* (non-mandatory)

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Not mandatory but keep section in document and leave empty/blank

Section 15: Regulatory Information* (non-mandatory)

Not mandatory but keep section in document and leave empty/blank

Section 16: Other Information

Section 16, Other information, includes the date of preparation or last revision.

*Note: Since other Agencies regulate this information, OSHA will not be enforcing Sections 12 through 15(29 CFR 1910.1200(g)(2)).

~Verified on 2014-07 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-07. ~

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GENERAL BUSINESS: 631-843-5500

http://www.henryschein.com

Henry Schein, Inc. 135 Duryea Road Melville, NY 11747

Safety Data Sheet

Section 1: Identification

Product Name TSE221-5USynonyms N/ACAS Number N/AProduct Use Silicone RubberManufacturer/Supplier GE Toshiba Silicones (Thailand) LtdAddress 1/2, MOO.4, Tumbol Banchang, Amphur, Rayong 50 21130

General Information 1-800-424-9300 (PRODUCT STEWARDSHIP COMPLIANCE AND STANDARDS)Transportation Emergency Number 1-800-424-9300

Section 2: Hazard(s) Identification

EMERGENCY OVERVIEWMay cause eye irritation. May generate formaldehyde at temperatures greater than 150C(300F).

POTENTIAL HEALTH EFFECT

SKIN Plant experience has shown that skin hazard is not applicable in this form

EYES May cause mild eye irritation

INGESTION None

INHALATION None

CHRONIC EFFECTS / CARCINOGENICITY This product or one of its ingredients present 0.1% or more is NOT listed as a carcinogen or suspected carcinogen by NTP, IARC, or OSHA.

OTHER This product contains methylpolysiloxanes which can generate formaldehyde at approximately 300degrees Fahrenheit (150'C) and above, in atmospheres which contain oxygen. Formaldehyde is a skin and respiratory sensitizer, eye and throat irritant, acute toxicant, and potential cancer hazard. An MSDS for formaldehyde is available from GE Silicones.

Section 3: Composition/Information on Ingredients

NON--HAZARDOUS CCOMPOSITION CCAS# WGT. %

Vinyl stopped Polydimethylsiloxane 68083-18-1 60 - 90 %

Silica 7631-86-9 10 - 30 %

Dimethylpolysiloxane 70131-67-8 1 - 5 %

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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Water 7732-18-5 1 - 5 %

Section 4: First-Aid Measures

INHALATION Move person to fresh air. Seek medical attention if symptoms of exposure develop.

SKIN Wash off with soap and water

EYES In case of contact, immediately flush eyes with plenty of water for at least 15 minutes and get medical attention if irritation persists.

INGESTION Do not induce vomiting. If victim is conscious, give 1-3 glasses of water to drink. Never giveanything by mouth to an unconscious person. Get medical attention if irritation persists.

Section 5: Fire-Fighting Measures

EXTINGUISHING MEDIA All standard firefighting media

SENSITIVITY TO MECHANICAL IMPACT No

SENSITIVITY TO STATIC DISCHARGE Sensitivity to static discharge is not expected

SPECIAL FIRE FIGHTING PROCEDURE Firefighters must wear NIOSH/MSHA approved positive pressure self-contained breathing apparatus with full face mask and full protective clothing

Section 6: Accidental Release Measures

ACTION TO BE TAKEN IF MATERIAL IS RELEASED OR SPILLED Wipe, scrape or soak up in an inert material and put in a container for disposal. Wear proper protective equipment as specified in the protective equipment section.

Section 7: Handling and Storage

Use only in area provided with appropriate exhaust ventilation. Avoid contact with eyes. Keep away from children. Curing releases vapors which may be harmful.

Section 8: Exposure Controls/Personal Protection

ENGINEERING CONTROLS Eyewash stations

RESPIRATORY PROTECTION If exposure limits are exceeded or respiratory irritation is experienced, NIOSH/MSHA approved respiratory protection should be worn. Supplied air respirators may be required for non-routine or emergency situations. Respiratory protection must be provided in accordance with OSHA regulations.

Eye protection Safety glasses

Protective gloves Cloth gloves

Other protection Wear suitable protective clothing and eye/face protection

Section 9: Physical and Chemical Properties

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BOILING POINT - C & F N/A

VAPOR PRESSURE (20 C) (MM HG) NEG

VAPOR DENSITY (AIR=1) Negligible

FREEZING POINT NA

MELTING POINT NA

PHYSICAL STATE Solid

ODOR None.

COLOR White

EVAPORATION RATE (BUTYL ACETATE=1) Negligible

SPECIFIC GRAVITY (WATER=1) Unknown

DENSITY (KG/M3) Unknown

ACID / ALKALINITY (MEQ/G) Unknown

pH NA

VOLATILE ORGANIC CONTENT (VOL) Unknown

SOLUBILITY IN WATER (20 C) Insoluble

SOLUBILITY IN ORGANIC SOLVENT (STATE SOLVENT) Unknown

VOC EXCL. H2O & EXEMPTS (G/L) No data

Section 10: Stability and Reactivity

STABILITY Stable

HAZARDOUS POLYMERIZATION Will not occur

Hazardous decomposition products Carbon dioxide(CO2), Formaldehyde, Carbon monoxide, Silicon dioxide

Section 11: Toxicological Information

No information is available

Section 12: Ecological Information* (non-mandatory)

No information is available

Section 13: Disposal Considerations* (non-mandatory)

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Disposal should be made in accordance with federal, state and local regulations.

Section 14: Transport Information* (non-mandatory)

N/A

Section 15: Regulatory Information* (non-mandatory)

US CLEAN AIR ACT, CLEAN WATER ACT, SARA SECTION 302, SARA (313) CHEMICALS

Canadian D2A VERY TOXIC MATERIALS

Other (CALIFORNIA PROPOSITION 65)This product does not contain any chemicals known to State of California to cause cancer, birth

defects or any other harm.

Section 16: Other Information

Reference

Version 1.1

Date 2004/05/27

*Note: Since other Agencies regulate this information, OSHA will not be enforcing Sections 12 through 15(29 CFR 1910.1200(g)(2)).

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HENRY SCHEIN PRIVATE LABEL PRODUCTS by this material

HS Part # Description

============= ============================================

MOUTH PROPS SERIES

100-8271 MOUTH PROP RUBBER BLACK -SMALL CHILD (2 PCS/PK)

100-6367 MOUTH PROP RUBBER BLACK -CHILD (2 PCS/PK)

100-0298 MOUTH PROP RUBBER BLACK -ADULT (2 PCS/PK)

900-9537 MOUTH PROP RUBBER BLACK -SMALL CHILD (2 PCS/PK)

900-9538 MOUTH PROP RUBBER BLACK -CHILD (2 PCS/PK)

900-9539 MOUTH PROP RUBBER BLACK -ADULT (2 PCS/PK)

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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MaxiCide® Plus Date Prepared: 12/3/14

Page 1 of 6

SAFETY DATA SHEET

Section 1. Product And Company Identification Product Name: MaxiCide® Plus Product Use: Liquid Sterilant/High Level Disinfectant Distributor: Henry Schein, Inc. 135 Duryea Road Melville, NY 11747 U.S.A. Information Phone Number: 1-800-472-4346 (Customer Service) Chemical Emergency Phone Number (Chemical Spills, Leaks, Fire, Exposure or Accident only): CHEMTREC 1-800-424-9300 (in the US) 1-703-527-3887 (Outside the US) SDS Date Of Preparation/Revision: 12/3/14

Section 2. Hazards Identification GHS / HAZCOM 2012 Classification: Eye Damage Category 1 Respiratory Sensitization Category 1 Label Elements Danger!

Hazard Phrases Causes serious eye damage. May cause allergy or asthma symptoms or breathing difficulties if inhaled. Prevention: Avoid breathing mist, vapors or spray. Wear eye protection and face protection. In case of inadequate ventilation wear respiratory protection. Response: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER. IF INHALED: remove person to fresh air and keep comfortable for breathing. If experiencing respiratory symptoms: Call a POISON CENTER. Storage and Disposal Dispose of contents and container in accordance with local and national regulations.

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Section 3. Composition/Information On Ingredients

Component CAS No. Amount Water and non-hazardous ingredients Mixture 97.5% Glutaraldehyde 111-30-8 3.4%

Section 4. First Aid Measures Eye Contact: Hold eye open and rinse slowly and gently with water for at least 15 minutes. Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. Seek immediate medical attention. Skin Contact: Wash thoroughly with soap and water. If skin irritation develops, seek medical attention. Inhalation: Move to fresh air. If ill effects occur, seek immediate medical attention. Ingestion: If swallowed, get immediate medical advice by calling a Poison Control Center or hospital emergency room. If advice is not available, take victim and product container to the nearest emergency treatment center or hospital. Do not induce vomiting unless directed to do so by medical personnel. If the victim is alert, rinse their mouth with water. Do not attempt to give anything by mouth to an unconscious person. Note to physician: Probable mucosal damage may contraindicate the use of gastric lavage. Most important symptoms and effects, acute and delayed: Corrosive to eyes. May cause skin and respiratory tract irritation. Ingestion of glutaraldehyde may cause nervous system effects including nausea, dizziness, headache, and drowsiness. Repeated inhalation of vapors may cause asthmatic symptoms in some individuals. Indication of immediate medical attention and special treatment, if needed: Treat symptomatically.

Section 5. Fire Fighting Measures Suitable (and Unsuitable) Extinguishing Media: Use any media that is suitable for the surrounding fire. Specific Hazards Arising from the Chemical: None known. Special Protective Equipment and Precautions for Fire-fighters: Firefighters should wear positive pressure self-contained breathing apparatus and full protective clothing for fires in areas where chemicals are used or stored.

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Section 6: Accidental Release Measures

Personal precautions, Protective equipment, and Emergency procedures: Wear appropriate protective clothing and equipment. Methods and Materials for Containment and Cleaning up: Stop leak if it is safe to do so and move containers from the spill area. Collect material with an inert absorbent material and place in appropriate, labeled container for disposal.

Section 7. Handling and Storage Precautions for Safe Handling: Avoid breathing vapors or mists. Prevent contact with eyes. Avoid contact with skin and clothing. Wash thoroughly with soap and water after handling. Avoid contamination of food. Use in a well-ventilated area in closed containers. Use in accordance with label directions. Conditions for Safe Storage, Including any Incompatibilities: Store at room temperature. Keep containers closed.

Section 8. Exposure Controls / Personal Protection Exposure Limits

Chemical Exposure Limit Glutaraldehyde 0.05 ppm Ceiling ACGIH TLV (SEN)

Appropriate Engineering Controls: Use general or local exhaust ventilation as needed to maintain airborne concentrations below the occupational exposure limits. Respiratory Protection: None under normal use conditions with adequate ventilation. For operations where exposure limits are exceeded, a NIOSH approved respirator with an organic vapor cartridge is recommended. Equipment selection depends on contaminant type and concentration. Select in accordance with 29 CFR 1910.134 and good industrial hygiene practice. For firefighting, use self-contained breathing apparatus. Hand protection: Protective gloves such as butyl rubber or nitrile are recommended to avoid skin contact. Eye Protection: Safety goggles recommended. Skin Protection: Wear protective clothing as needed to avoid skin contact. Hygiene measures: Suitable eye wash and washing facilities should be available in the work area.

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MaxiCide® Plus Date Prepared: 12/3/14

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Section 9. Physical and Chemical Properties Appearance: Clear, colorless

liquid Odor: Fruity odor.

Odor Threshold: 0.038 ppm (glutaraldehyde)

pH: 3.2-4.3 inactivated, 6.5-8.5 activated

Melting/Freezing Point:

Not available Boiling Point/Range:

100°C (212°F)

Flash Point: Not flammable Evaporation Rate: Not available Flammability: (Solid, Gas)

Not applicable Flammability Limits:

Not applicable

Vapor Pressure: 0.3 mmHg @20°C (glutaraldehyde)

Vapor Density: Not available

Relative Density: >1.0 Solubilities: Soluble in Water Partition Coefficient: (N-Octanol/Water)

Not available Autoignition Temperature:

Not flammable

Decomposition Temperature:

Not available Viscosity: Not available

Section 10. Stability and Reactivity Reactivity: None known. Chemical Stability: Stable. Possibility of Hazardous Reactions: None known. Conditions to avoid: Avoid temperatures above 100°C. Do not allow significant evaporation. Incompatible Materials: Strong oxidizing agents, acids and bases. Hazardous decomposition products: Thermal decomposition will produce carbon monoxide and carbon dioxide.

Section 11. Toxicological Information Potential Health Effects: Inhalation: Vapors may cause irritation of the nose, throat and upper respiratory tract. Repeated inhalation of glutaraldehyde vapors may cause asthmatic symptoms in some individuals, including cough, wheezing and difficulty breathing. Skin Contact: May cause skin irritation. No signs of toxicity were observed in a dermal toxicity study in rabbits. Irritating in a primary irritation study with rabbits, effects reversed in 72 hrs. Negative in a skin sensitization study with guinea pigs. Eye Contact: Causes severe irritation and possible eye damage. Corrosive in an eye irritation study in rabbits. Ingestion: Do not ingest. If swallowed, may irritate mouth, throat and intestinal tract. Ingestion of glutaraldehyde may cause nervous system effects including nausea, dizziness, headache, and drowsiness.

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MaxiCide® Plus Date Prepared: 12/3/14

Page 5 of 6

Chronic Hazards: No adverse effects expected based on the available data. Carcinogen: None of the components is listed as a carcinogen or potential carcinogen by IARC, NTP, ACGIH, or OSHA. Acute Toxicity Values for MetriCide: LD50 Oral Rat 3450 mg/kg; LD50 Dermal Rabbit >2000 mg/kg

Section 12. Ecological Information This product is classified as toxic to the aquatic environment. Toxicity: No toxicity data available for product. Glutaraldehyde: LC50 fathead minnow 10.8 mg/L/96 hr; EC50 daphnia magna 0.69 mg/L/48 hr; EbC50 green algae 2.64 mg/L/72 hr. Persistence and degradability: Glutaraldehyde is readily biodegradable. Bioaccumulative Potential: Glutaraldehyde: log Kow -0.333, potential for bioaccumulation is low Mobility in Soil: Glutaraldehyde: highly mobile in soil. Other Adverse Effects: None known

Section 13. Disposal Considerations Solution Disposal: Refer to product label for disposal information. Dispose in accordance with national, state/provincial and local regulations. Container Disposal: Nonrefillable container. Do not reuse or refill this container. Offer for recycling, if availab le. If recycling is not available, discard in accordance with hospital policy.

Section 14. Transport Information UN Number UN Proper Shipping Name Hazard

Class(s) Packing Group

Environmental Hazards

US DOT None Not Regulated None EU ADR/RID None Not Regulated None IMDG None Not Regulated None IATA/ICAO None Not Regulated None

Section 15. Regulatory Information U.S. Federal Regulations: EPA SARA 311/312 Hazard Classification: Acute Health

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EPA SARA 313: This Product Contains the Following Chemicals Subject to Annual Release Reporting Requirements Under SARA Title III, Section 313 (40 CFR 372): None Protection Of Stratospheric Ozone: This product is not known to contain or to have been manufactured with ozone depleting substances as defined in 40 CFR Part 82, Appendix A to Subpart A. CERCLA SECTION 103: This product is not subject to CERCLA reporting requirements; however, many states have more stringent release reporting requirements. Report spills required under federal, state and local regulations. California Prop 65: This product may contain a chemical known to the State of California to cause cancer or birth defects or other reproductive harm. International Inventories US EPA TSCA Inventory: All of the components of this product are listed on the Toxic Substances Control Act (TSCA) Chemical Substances Inventory or exempt. Canadian Environmental Protection Act: All of the components in this product are listed on the Domestic Substances List (DSL) or exempt.

Section 16. Other Information NFPA Rating: Fire: 1 Health: 3 Instability: 0 Effective Date: 12/3/14 Supersedes Date: 11/1/2012 Revision Summary: New GHS Formatted SDS The information and recommendations set forth herein are taken from sources believed to be accurate as of the date of preparation, however, METREX RESEARCH makes no warranty with respect to the accuracy or suitability of the recommendations, and assumes no liability to any use thereof.

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Safety Data Sheet Hydrogen Peroxide 3% USP

SDS Revision Date: 02/10/2015

001 - Hydrogen Peroxide 3% USP Page 1 of 8

1. Identification 1.1. Product identifier

Product Identity Hydrogen Peroxide 3% USP Alternate Names Product Number: 112-7012, 112-7069, 112-7070 1.2. Relevant identified uses of the substance or mixture and uses advised against

Intended use First aid to help prevent risk of infection; Aids in the removal of phlegm, mucous or other oral secretions

Application Method First aid antiseptic: apply a small amount of product on affected area 1 to 3 times daily Oral rinse: mix with an equal amount of water and swish around mouth up to 4 times daily

1.3. Details of the supplier of the safety data sheet

Company Name

Emergency

Chemtrec 24 hour Emergency Telephone No. 800-424-9300

Customer Service 800-472-4346

2. Hazard(s) identification 2.1. Classification of the substance or mixture

Skin Corr. 1B;H314 Causes severe skin burns and eye damage.

Eye Dam. 1;H318 Causes serious eye damage.

2.2. Label elements Using the Toxicity Data listed in section 11 and 12 the product is labeled as follows.

Danger

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Safety Data Sheet Hydrogen Peroxide 3% USP

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001 - Hydrogen Peroxide 3% USP Page 2 of 8

H314 Causes severe skin burns and eye damage.

H318 Causes serious eye damage.

[Prevention]:

P260 Do not breathe mist / vapors / spray.

P264 Wash thoroughly after handling.

P280 Wear protective gloves / eye protection / face protection.

[Response]:

P301+330+331 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Stay at rest.

P303+361+353 IF ON SKIN (or hair): Remove / Take off immediately all contaminated clothing. Rinse skin with water / shower.

P304+340 IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

P305+351+338 IF IN EYES: Rinse continuously with water for several minutes. Remove contact lenses if present and easy to do - continue rinsing.

P310 Immediately call a POISON CENTER or doctor / physician.

P363 Wash contaminated clothing before reuse. [Storage]:

P405 Store locked up.

[Disposal]:

P501 Dispose of contents / container in accordance with local / national regulations.

3. Composition/information on ingredients This product contains the following substances that present a hazard within the meaning of the relevant State and Federal Hazardous Substances regulations.

Ingredient/Chemical Designations Weight % GHS Classification Notes

Hydrogen peroxide CAS Number: 0007722-84-1

1.0 - 10 Ox. Liq. 1;H271 Acute Tox. 4;H332 Acute Tox. 4;H302 Skin Corr. 1A;H314

[1][2]

[1] Substance classified with a health or environmental hazard. [2] Substance with a workplace exposure limit. [3] PBT-substance or vPvB-substance. *The full texts of the phrases are shown in Section 16.

4. First aid measures 4.1. Description of first aid measures

General In all cases of doubt, or when symptoms persist, seek medical attention. Never give anything by mouth to an unconscious person.

Inhalation Remove to fresh air, keep patient warm and at rest. If breathing is irregular or stopped, give artificial respiration. If unconscious place in the recovery position and obtain immediate medical attention. Give nothing by mouth.

Eyes Irrigate copiously with clean water for at least 15 minutes, holding the eyelids apart and seek medical attention.

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Safety Data Sheet Hydrogen Peroxide 3% USP

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001 - Hydrogen Peroxide 3% USP Page 3 of 8

Skin Remove contaminated clothing. Wash skin thoroughly with soap and water or use a recognized skin cleanser.

Ingestion If swallowed do NOT induce vomiting and obtain immediate medical attention.

4.2. Most important symptoms and effects, both acute and delayed

Overview Inhalation of vapors and mists irritate the nose and throat. Minimally irritating to the eyes and mildly irritating to the skin. See section 2 for further details.

Eyes Causes serious eye damage. Skin Causes severe skin burns and eye damage.

5. Fire-fighting measures 5.1. Extinguishing media Recommended extinguishing media; Flood with water spray of water fog.

5.2. Special hazards arising from the substance or mixture Hazardous decomposition: Oxygen, which supports combustion.

Do not breathe mist / vapors / spray.

5.3. Advice for fire-fighters Fire fighters should wear positive pressure self-contained breathing apparatus (SCBA) and full turnout gear.

ERG Guide No. ----

6. Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures Put on appropriate personal protective equipment (see section 8).

6.2. Environmental precautions Biodegradable, non-hazardous to environment.

Use good personal hygiene practices. Wash hands before eating, drinking, smoking or using toilet. Promptly remove soiled clothing and wash thoroughly before reuse.

6.3. Methods and material for containment and cleaning up Flush with water: wear rubber boots, rubber apron and goggles.

7. Handling and storage 7.1. Precautions for safe handling See section 2 for further details. - [Prevention]:

7.2. Conditions for safe storage, including any incompatibilities Handle containers carefully to prevent damage and spillage.

Incompatible materials: Reducing agents, combustible materials.

Store in a cool, dark place. Avoid extreme heat.

See section 2 for further details. - [Storage]:

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001 - Hydrogen Peroxide 3% USP Page 4 of 8

7.3. Specific end use(s) No data available.

8. Exposure controls and personal protection 8.1. Control parameters

Exposure

CAS No. Ingredient Source Value

0007722-84-1 Hydrogen peroxide OSHA TWA 1 ppm (1.4 mg/m3)

ACGIH TWA: 1 ppm

NIOSH TWA 1 ppm (1.4 mg/m3)

Supplier No Established Limit

Carcinogen Data CAS No. Ingredient Source Value

0007722-84-1 Hydrogen peroxide OSHA Select Carcinogen: No

NTP Known: No; Suspected: No

IARC Group 1: No; Group 2a: No; Group 2b: No; Group 3: Yes; Group 4: No;

8.2. Exposure controls

Respiratory If workers are exposed to concentrations above the exposure limit they must use the appropriate, certified respirators.

Eyes Protective goggles if desired.

Skin Rubber or vinyl gloves.

Engineering Controls Provide adequate ventilation. Where reasonably practicable this should be achieved by the use of local exhaust ventilation and good general extraction. If these are not sufficient to maintain concentrations of particulates and any vapor below occupational exposure limits suitable respiratory protection must be worn.

Other Work Practices Use good personal hygiene practices. Wash hands before eating, drinking, smoking or using toilet. Promptly remove soiled clothing and wash thoroughly before reuse.

See section 2 for further details. - [Prevention]:

9. Physical and chemical properties Appearance Clear, Colorless Liquid

Odor Odorless

Odor threshold Not Measured

pH Not Available

Melting point / freezing point Not Available

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Safety Data Sheet Hydrogen Peroxide 3% USP

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001 - Hydrogen Peroxide 3% USP Page 5 of 8

Initial boiling point and boiling range 212ºF Flash Point Not Applicable

Evaporation rate (Butyl Acetate = 1) > 1

Flammability (solid, gas) Not Applicable

Upper/lower flammability or explosive limits Lower Explosive Limit: Not Applicable

Upper Explosive Limit: Not Applicable

Vapor pressure (Pa) 23 mmHg Vapor Density Not Available

Specific Gravity (H2O = 1) 1.1

Solubility in Water Complete

Partition coefficient n-octanol/water (Log Kow) Not Measured

Auto-ignition temperature Not Measured

Decomposition temperature Not Measured Viscosity (cSt) Not Measured

Heavy Metals 5 ppm maximum

Limit of Preservative NMT 50 mg

Hydrogen Peroxide Assay 2.5%-3.5%

9.2. Other information No other relevant information.

10. Stability and reactivity 10.1. Reactivity Hazardous Polymerization will not occur.

10.2. Chemical stability Stable under normal circumstances.

10.3. Possibility of hazardous reactions No data available. 10.4. Conditions to avoid Extreme heat and contamination.

10.5. Incompatible materials Reducing agents, combustible materials.

10.6. Hazardous decomposition products Oxygen, which supports combustion.

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Safety Data Sheet Hydrogen Peroxide 3% USP

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001 - Hydrogen Peroxide 3% USP Page 6 of 8

11. Toxicological information

Acute toxicity

Ingredient Oral LD50, mg/kg

Skin LD50, mg/kg

Inhalation Vapor LD50,

mg/L/4hr

Inhalation Dust/Mist LD50,

mg/L/4hr

Inhalation Gas LD50,

ppm

Hydrogen peroxide - (7722-84-1) 801.00, Rat - Category: 4

2,000.00, Rat - Category: 4

2.00, Rat - Category: 2

No data available

No data available

Note: When no route specific LD50 data is available for an acute toxin, the converted acute toxicity point estimate was used in the calculation of the product's ATE (Acute Toxicity Estimate).

Classification Category Hazard Description

Acute toxicity (oral) --- Not Applicable

Acute toxicity (dermal) --- Not Applicable

Acute toxicity (inhalation) --- Not Applicable

Skin corrosion/irritation 1B Causes severe skin burns and eye damage.

Serious eye damage/irritation 1 Causes serious eye damage.

Respiratory sensitization --- Not Applicable

Skin sensitization --- Not Applicable

Germ cell mutagenicity --- Not Applicable

Carcinogenicity --- Not Applicable

Reproductive toxicity --- Not Applicable

STOT-single exposure --- Not Applicable

STOT-repeated exposure --- Not Applicable

Aspiration hazard --- Not Applicable

12. Ecological information

12.1. Toxicity No additional information provided for this product. See Section 3 for chemical specific data.

Aquatic Ecotoxicity

Ingredient 96 hr LC50 fish, mg/l

48 hr EC50 crustacea, mg/l

ErC50 algae, mg/l

Hydrogen peroxide - (7722-84-1) 22.00, Oncorhynchus mykiss

2.32, Daphnia magna 0.71 (72 hr), Microcystis pulverea ssp. incerta

12.2. Persistence and degradability

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There is no data available on the preparation itself. 12.3. Bioaccumulative potential Not Measured

12.4. Mobility in soil No data available.

12.5. Results of PBT and vPvB assessment This product contains no PBT/vPvB chemicals. 12.6. Other adverse effects No data available.

13. Disposal considerations 13.1. Waste treatment methods Observe all federal, state and local regulations when disposing of this substance.

14. Transport information DOT (Domestic Surface

Transportation) IMO / IMDG (Ocean Transportation)

ICAO/IATA

14.1. UN number Not Applicable Not Regulated Not Regulated 14.2. UN proper shipping name

Not Regulated Not Regulated Not Regulated

14.3. Transport hazard class(es)

DOT Hazard Class: Not Applicable DOT Label: ---

IMDG: Not Applicable Sub Class: Not Applicable

Air Class: Not Applicable

14.4. Packing group Not Applicable Not Applicable Not Applicable

14.5. Environmental hazards

IMDG Marine Pollutant: No

14.6. Special precautions for user No further information

15. Regulatory information Regulatory Overview The regulatory data in Section 15 is not intended to be all-inclusive, only selected

regulations are represented. Toxic Substance Control Act ( TSCA)

All components of this material are either listed or exempt from listing on the TSCA Inventory.

WHMIS Classification D2B E

US EPA Tier II Hazards Fire: No

Sudden Release of Pressure: No

Reactive: No

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Safety Data Sheet Hydrogen Peroxide 3% USP

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001 - Hydrogen Peroxide 3% USP Page 8 of 8

Immediate (Acute): Yes Delayed (Chronic): No

EPCRA 311/312 Chemicals and RQs: To the best of our knowledge, there are no chemicals at levels which require reporting under this statute.

EPCRA 302 Extremely Hazardous: Hydrogen peroxide

EPCRA 313 Toxic Chemicals: To the best of our knowledge, there are no chemicals at levels which require reporting under this statute.

Proposition 65 - Carcinogens (>0.0%): To the best of our knowledge, there are no chemicals at levels which require reporting under this statute.

Proposition 65 - Developmental Toxins (>0.0%): To the best of our knowledge, there are no chemicals at levels which require reporting under this statute.

Proposition 65 - Female Repro Toxins (>0.0%): To the best of our knowledge, there are no chemicals at levels which require reporting under this statute.

Proposition 65 - Male Repro Toxins (>0.0%): To the best of our knowledge, there are no chemicals at levels which require reporting under this statute.

New Jersey RTK Substances (>1%): Hydrogen peroxide

Pennsylvania RTK Substances (>1%): Hydrogen peroxide

16. Other information The information and recommendations contained herein are based upon data believed to be correct. However, no guarantee or warranty of any kind, expressed or implied, is made with respect to the information contained herein. We accept no responsibility and disclaim all liability for any harmful effects which may be caused by exposure to our products. Customers/users of this product must comply with all applicable health and safety laws, regulations, and orders.

The full text of the phrases appearing in section 3 is:

H271 May cause fire or explosion; strong oxidizer.

H302 Harmful if swallowed.

H314 Causes severe skin burns and eye damage.

H332 Harmful if inhaled.

This is the first version in the GHS SDS format. Listings of changes from previous versions in other formats are not applicable.

Disclaimer: The contents of this MSDS are believed to be correct but do not purport to be all-inclusive and should only be used as a guide. Henry Schein Inc. disclaims any express or implied warranty as to the accuracy of the above information and shall not be held liable for any direct, incidental or consequential damages resulting from the reliance on the above information.

End of Document

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SAFETY DATA SHEET

Issue Date 26-Sept-2014 Revision Date Version 1

1. IDENTIFICATION

Product Identifier Product Name ORTHO-JET LIQUID

Other means of identification SDS# 039 UN/ID No UN1993 Product Code 1303, 1304, 1306, 1307, 1308, 1309, 1323, 1334, 1356

Recommended use of the chemical and restrictions on use Recommended Use Fabrication of orthodontic appliances

Details of the supplier of the safety data sheet Supplier Address Lang Dental Mfg. Co., Inc. 175 Messner Dr. Wheeling, IL 60090 USA

Emergency telephone number Company Phone Number 847-215-6622 Emergency Telephone (INFOTRAC) 352-323-3500 (International) 800-535-5053 (North America)

2. HAZARDS IDENTIFICATION Classification Acute toxicity �� Inhalation (Dusts/Mists) Category 4 Skin corrosion / irritation Category 2 Serious eye damage / eye irritation Category 2 Skin sensitization Category 1 Specific target organ toxicity (single exposure) Category 3 Specific target organ toxicity (repeated exposure) Category 2 Flammable liquids Category 2 Signal word Danger Hazard statements Harmful if inhaled.

Causes skin irritation. Causes severe eye irritation. May cause an allergic skin reaction. May cause respiratory irritation. May cause drowsiness or dizziness. May cause damage to organs through prolonged or repeated exposure.

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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Highly flammable liquid and vapor.

Appearance Clear to slightly tinted Physical state Liquid Odor Acrid Precautionary Statements �� Prevention Use only outdoors or in a well-ventilated area. Wash face, hands and any exposed skin thoroughly after handling. Wear protective gloves and clothing. Wear eye and face protection. Contaminated clothing should not be allowed out of the workplace. Do not breathe dust, fume, gas, mist, vapors or spray. Keep away from heat, spark, open flame and hot surface. NO SMOKING. Keep container tightly closed. Ground/bond container and receiving equipment. Use explosion-proof equipment. Use only non-sparking tools. Take precautionary measures against static discharge. Keep cool. Precautionary Statements �� Response IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. If skin irritation or rash occurs, get medical advice/attention. IF ON SKIN (or hair): Remove/take off immediately all contaminated clothing. Rinse skin with water/shower. Wash contaminated clothing before reuse. IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Immediately call a POISON CENTER or doctor/physician. IN CASE OF FIRE: Use CO2, dry chemical or foam for extinction. Precautionary Statements �� Storage Store in a well-ventilated place.

Keep container tightly closed. Store locked up.

Precautionary Statements �� Disposal Dispose of contents/container to an approved waste disposal plant. Hazards not otherwise classified (HNOC) May be harmful if swallowed Other Information Harmful to aquatic life with long lasting effects

Harmful to aquatic life

3. COMPOSITION / INFORMATION ON INGREDIENTS

Chemical Name CAS No Weight - % Trade Secret Methyl Methacrylate 80-62-6 >95 *

N, N-Dimethyl-p-Toluidine 99-97-8 <2 * *Specific chemical weight has been withheld as a trade secret.

4. FIRST AID MEASURES First aid measures

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Inhalation Remove victim to fresh air and keep at res in a position comfortable for breathing. Call a physician or poison

control center immediately. Eye contact Immediately flush with plenty of water. After initial flushing, remove any contact lenses and continue flushing

for at least 15 minutes. Call a physician immediately. Ingestion Do NOT induce vomiting. Drink plenty of water or milk immediately. Never give anything by mouth to an

unconscious person. Provide an estimate of the time at which the material was ingested and the amount of the substance that was swallowed. Call a physician or poison control center immediately.

Skin Contact Wash off immediately with plenty of soap and water. Take off contaminated clothing. Wash contaminated

clothing before reuse. If skin irritation or rash occurs, get medical advice/attention. Most important symptoms and effects, both acute and delayed Symptoms Exposed individuals may experience eye tearing, redness and discomfort. Contact may cause irritation and

redness. Prolonged exposure in poorly ventilated area may cause respiratory irritation. Indication of any immediate medical attention and special treatment needed Note to physicians Treat symptoms conventionally, after thorough decontamination.

5. FIRE-FIGHTING MEASURES Extinguishing Media Suitable: Chemical foam, carbon dioxide (CO2), dry chemical Unsuitable: Water spray Specific hazards arising from the chemical For bulk size >1L �� High temperatures, inhibitor depletion, accidental impurities, or exposure to radiation or oxidizers may cause spontaneous polymerizing reaction generating heat/pressure. Closed containers may rupture or explode during a runaway polymerization. Use a water spray or fog to reduce or direct vapors. Extremely flammable. Vapors are heavier than air and may spread along the floors. Vapors may travel to source of ignition and flash back. Heat/impurities may cause pressure to build and/or rupture closed containers, spreading fire, increasing risk or burns/injuries. Hazardous Combustion Products: Carbon oxides Sensitivity to Mechanical Impact: No Sensitivity to Static Discharge: Yes Protective equipment and precautions for firefighters As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent) and full protective gear. Fight fire from a safe location.

6. ACCIDENTAL RELEASE MEASURES Personal precautions, protective equipment and emergency procedures Personal precautions ELIMINATE all ignition sources (no smoking, flares, sparks or flames in immediate area). Use

personal protective equipment as required. Ensure adequate ventilation. Remove any contaminated clothing and wash thoroughly before reuse.

Environmental precautions Prevent product from entering drains. Spillages or uncontrolled discharges into watercourses must

be alerted to the appropriate regulatory body. Methods and material for containment and clean-up

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Method for containment Absorb with earth, sand or other non-combustible material and transfer to containers for later disposal. DO NOT use combustible materials such as sawdust.

Method for clean-up Use only non-sparking tools. Wash all affected areas with plenty of warm water and soap.

7. HANDLING AND STORAGE Precautions for safe handling Advice on safe handling Observe precautions found on the label. Keep containers closed when not in use. All equipment

used when handling the product must be grounded. Use spark-proof tools and explosion-proof equipment. Avoid contact with skin, eyes and clothing. Use only in well-ventilated areas. Vapors are heavier than air and may travel along the floor and in the bottom of containers. Take precautionary measures against static discharges. Keep away from heat, sparks, open flames, and hot surfaces. NO SMOKING. Use personal protection recommended in Section 8. Wash thoroughly after handling. Contaminated work clothing should not be allowed out of the workplace. Do not breathe dust, fume, gas, mist, vapor or spray.

Conditions for safe storage, including any incompatibilities Storage Conditions Keep containers tightly closed in a dry, cool and well-ventilated place. Keep away from heat,

sparks, flame and other sources of ignition (i.e. pilot lights, electric motors and static electricity). Protect from direct sunlight. Keep container closed to prevent water absorption and contamination. Methacrylate stored in bulk must be kept in contact with air (oxygen). Keep at a temperature not exceeding 25°C.

Packaging materials Keep in original container. Incompatible materials Strong oxidizing agents, strong reducing agents, free-radical generators, inert gases, oxygen

scavengers Material has strong solvent properties and can soften paint and rubber.

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Exposure guidelines Consideration should be given to the work procedures involved and the potential extent of

exposure as they may determine whether a higher level of protection is required. The following information is given as general guidance.

Chemical Name ACGIH TLV OSHA PEL NIOSH IDLH

Methyl Methacrylate 80-62-6

STEL: 100 ppm TWA: 50 ppm

TWA:100 ppm TWA: 410 mg/m3

TWA:100 ppm (vacated) TWA: 410 mg/m3 (vacated)

IDLH: 1000 ppm TWA: 100 ppm

TWA: 410 mg/m3

Appropriate engineering controls Engineering controls Apply technical measures to comply with the occupational exposure limits. Eyewash stations Individual protection measures, such as personal protective equipment Eye / face protection Depending on the use of this product, safety glasses or goggles may be worn. If necessary, refer to

US OSHA 29CFR SS1910.133, Canadian standards or the European Standard EN 166. Ensure that an eyewash station, sink or washbasin is available in case of exposure to eyes.

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Skin and body protection If anticipated that prolonged and repeated skin contact will occur during use of this product, wear gloves for routine industrial use. If necessary, refer to US OSHA 29CFR SS1910.138 or the appropriate standards of Canada or the EC member states. Wear suitable protective clothing.

Respiratory protection Wear suitable respiratory equipment if exposure to levels above the occupational exposure limit is

likely. A suitable mask with filter type A may be appropriate. In the event of formation of particularly high levels of vapor, a self-contained breathing apparatus may be appropriate.

General hygiene considerations Handle in accordance with good industrial hygiene and safety practice.

9. PHYSICAL AND CHEMICAL PROPERTIES Information on basic physical and chemical properties Physical state Liquid Odor Acrid Appearance Liquid Odor threshold Not determined Color Clear to slightly tinted Property Values Remarks / Method pH Not determined Melting point / freezing point Not determined Boiling point / boiling range 101°C / 214° F Flash point 11.5°C / 52.7°F Evaporation rate 3.1 Butyl acetate = 1 Flammability (solid, gas) n/a (liquid) Flammability limits in air Upper flammability limit 12.5% Lower flammability limit 2.12% Vapor pressure 28mm Hg @ 20°C Vapor density 3.5 @15.5°C (Air = 1) Specific gravity 0.949 Water = 1 Water solubility 1.6 wt% Solubility in other solvents Not determined Partition coefficient Not determined Autoignition temperature 421°C / 790°F Decomposition temperature Not determined Kinematic viscosity Not determined Dynamic viscosity Like water Explosive properties Not determined Oxidizing properties Not determined Other information Density 0.949 g/mL

10. STABILITY AND REACTIVITY Reactivity Not reactive under normal conditions Chemical stability Unstable / reactive upon depletion of inhibitor Possibility of hazardous reactions None under normal processing

Hazardous polymerization Hazardous polymerization may occur. Monomer vapors are inhibited and may form polymers in vent or flame arresters, resulting in blockage of vents.

Conditions to avoid

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Temperatures above 25°C (77°F), localized heat sources (e.g. drum or band heaters), oxidizing conditions, freezing conditions, direct sunlight, ultraviolet radiation, inert gas blanketing Incompatible materials Strong oxidizing agents, strong reducing agents, free-radical generators, inert gases, oxygen scavengers Material has strong solvent properties and can soften paint and rubber. Hazardous decomposition products Carbon oxides

11. TOXICOLOGICAL INFORMATION Information on likely routes of exposures Product information Inhalation Harmful if inhaled. Eye contact Causes severe eye irritation. Skin contact Causes skin irritation. Ingestion May be harmful if swallowed. Component information

Chemical Name ORAL LD50 DERMAL LD50 INHALATION LC50 Methyl Methacrylate

80-62-6 7872 mg/kg (rat) >5 g/kg (rabbit) 400 ppm (rat) 1 h

4632 ppm (rat) 4 h N, N-Dimethyl-p-Toluidine

99-97-8 1650 mg/kg (rat) - 1400 mg/m3 (rat) 4 h

Information on physical, chemical and toxicological effects Symptoms Contact may cause irritation and redness. Exposed individuals may experience eye tearing, redness and

discomfort. Prolonged exposure in poorly ventilated area may cause respiratory irritation. Delayed and immediate effects as well as chronic effects from short and long-term exposure Sensitization May cause allergic skin reaction. Carcinogenicity Not classifiable as a human carcinogen

Chemical Name ACGIH IARC NTP OSHA Methyl Methacrylate

80-62-6 Group 3

IARC (International Agency for Research on Cancer) �*�U�R�X�S�������,���5� � ���F�R�P�S�R�Q�H�Q�W�V���D�U�H�����Q�R�W�� �F�O�D�V�V�L�I�L�D�E�O�H���D�V���K�X�P�D�Q���F�D�U�F�L�Q�R�J�H�Q�V�� STOT �� single exposure May cause respiratory irritation. May cause drowsiness or dizziness. STOT �� repeated exposure May cause damage to organs through prolonged or repeated exposure: liver, kidney, nose. Numerical measures of toxicity �� Product Not determined The following values are calculated based on chapter 3.1 of the GHS document.

ATEmix (oral) 3082 mg/kg ATEmix (dermal) 5107 mg/kg ATEmix (inhalation-dust/mist) 6848 ppm

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12. ECOLOGICAL INFORMATION Ecotoxicity Harmful to aquatic life with long-lasting effects Chemical Name Algae / aquatic plants Fish Toxicity to

microorganisms Crustacea

Methyl Methacrylate

80-62-6

170: 96 h Psuedokirchneriella

subcapitata mg/L EC50

125.5-190.7: 96 h Pimephales promelas mg/L LC50 static;

153.9-341.8: 96 h Lepomis macrochirus mg/L LC50 static;

170-206: 96 h Lepomis macrochirus mg/L LC50 flow-through;

243-275: 96 h Pimephales promelas mg/L LC50 flow-through;

326.4-426.9 96 h Poecilia reticulata mg/L LC50 static;

>79: 96 h Oncorhynchus mykiss mg/L LC50 flow-through;

>79: 96 h Oncorhynchus mykiss mg/L LC50 static

69: 48 h Daphnia magna mg/L EC50

N,N-Dimethyl-p-Toluidine 99-97-8

42-50.5: 96 h Pimphales promelas mg/L LC50 flow-through

Persistence and degradability Not readily biodegradable Bioaccumulation Not determined Mobility Potential for mobility in soil is very high.

Chemical Name Partition coefficient Methyl Methacrylate

80-62-6 0.7

Other adverse effects COD = 88% (28 days), DOC removal > 95% (28 days)

13. DISPOSAL CONSIDERATIONS Waste treatment methods Disposal of wastes Dispose of in accordance with federal, state and local regulations. When discarded, it is considered

a hazardous waste by the EPA under RCRA. The reportable quantity for methyl methacrylate is 1000 lb. (40 CFR Part 302). Add excess inhibitor before disposing.

Contaminated Packaging Reuse of empty drums or containers is not recommended. Employees should be advised of the

potential hazards due to residual material associated with empty containers. Dispose of all empty containers properly in accordance with federal, state and local regulations.

Chemical Name RCRA RCRA �� Basis for Listing RCRA �� D Series Wastes RCRA �� U Series Wastes

Methyl Methacrylate 80-62-6

U162 Included in waste stream; F039

U162

Chemical Name California Hazardous Waste Status

Methyl Methacrylate 80-62-6

Toxic Ignitable

14. TRANSPORTATION INFORMATION

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DOT

UN / ID No UN1993 Proper shipping name Flammable liquid, n.o.s. (Methyl Methacrylate monomer, stabilized /

N,N-Dimeythl-p-Toluidine solution) Hazard Class 3 Packing Group II Reportable Quantity (RQ) 1000 lb. (methyl methacrylate)

IATA

UN / ID No UN1993 Proper shipping name Flammable liquid, n.o.s. (Methyl Methacrylate monomer, stabilized /

N,N-Dimeythl-p-Toluidine solution) Hazard Class 3 Packing Group II

IMDG

UN / ID No UN1993 Proper shipping name Flammable liquid, n.o.s. (Methyl Methacrylate monomer, stabilized /

N,N-Dimeythl-p-Toluidine solution) Hazard Class 3 Packing Group II

15. REGULATORY INFORMATION International Inventories TSCA Listed United States Toxic Substances Control Act, Section 8(b) Inventory DSL Listed Canadian Domestic Substances List EINECS Listed European Inventory of Existing Chemical Substances US Federal Regulations

Chemical Name CAS Weight % SARA 313 Threshold Values % Methyl Methacrylate 80-62-6 >95 1.0

SARA 311 / 312 Hazard Categories

Chemical Name CWA �� Reportable Quantities

CWA �� Toxic Pollutants

CWA �� Priority Pollutants

CWA �� Hazardous Substances

Methyl Methacrylate 80-62-6

1000 lb. X

Chemical Name Hazardous Substances

RQs CERCLA / SARA RQ

Reportable Quantity (RQ) Final

Methyl Methacrylate 80-62-6

1000 lb. 1000 lb. / 454 kg

US State Right-to-Know Regulations

Chemical Name New Jersey Massachusetts Pennsylvania Methyl Methacrylate

80-62-6 X X X

16. OTHER INFORMATION NFPA Health Hazards Flammability Instability 2 3 2

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HMIS Health Hazards Flammability Physical Hazards 2 3 2 Issue Date 26-Sept-2014 Revision Date Revision Note Disclaimer The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release. It is not to be considered a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other materials or in any process, unless specified in the text.

End of Safety Data Sheet

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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SAFETY DATA SHEET 1. Identification: Name of Product: ALUWAX Recommended use: Dental Impressions, Bite Registration Producer: ALUWAX DENTAL PRODUCTS CO. 5260 EDGEWATER DRIVE ALLENDALE, MI 49401 PH. 616.895.4385 FAX 616.895.5060 Emergency no. 616.895.4385 2. Hazard Identification: No Known Hazardous Ingredients (Paraffin and Beeswax) Trade Secret/CBI Precautionary Statements: Store in original box and keep closed when not in use. Keep away from heat sources: open flame, heat pipes/ducts Store at room temperatures (15-27 degrees C.) 3. Composition/Information on ingredients: Paraffin CAS No. 8002-74-2 Beeswax CAS No. 8012-89-3 Aluminum CAS No. 7429-90-5 CBI-No Known Hazardous Ingredients 4. First-aid measures: Extended inhalation of high concentrations of fumes may cause dizziness, headache, and respiratory irritation. If burned by molten product, quench immediately with cold tap water. Dry burn area and loosely cover to protect against infection. Do not apply ointments or salves. Consult physician if burn is severe or cover a large area. If overcome by fumes, remove from area/exposure and call physician. 5. Firefighting measures: Suitable extinguishing media: foam, dry chemical, water fog, CO2. In case of fire, cool exposed containers with water fog. Unsuitable extinguishing media: High pressure water (jet) Specific hazards in case of fire: partial burning produces fumes, smoke, and carbon monoxide. Specific protective equipment and precautions for fire fighters: For fires in enclosed areas, wear self-contained breathing apparatus. Avoid breathing fumes. 6. Accidental release measures: Personal precautions: Eliminate heat sources and open flame. (also see section 7)

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Environmental precautions: N/A Methods and materials for containment and clean up: Eliminate heat sources and open flame. Shovel up and dispose of in an appropriate waste disposal facility in accordance with current applicable laws and regulations. (also see section 13) 7. Handling and storage: Precautions for safe handling: Good hygienic practices recommended. Conditions for safe storage, including incompatibilities: Store away from heat sources. Store at room temperature (15-27 degrees C.) and in original boxes closed when not in use. 8. Exposure controls / personal protection Information on system design: Good hygiene practices are recommended. Ventilation, Respiratory, Eye, Skin Protection: Normally not required. Products are all stable. 9. Physical and chemical properties Physical state: solid Colour: Light grey/green Odour: Light beeswax aroma Odour threshold: Not available pH-value: Not available Melting point: 49-53 degrees C. +/- 1 degree / 120-127 degrees F. +/- 1 degree Freezing point: Not available Initial boiling point: 265+ degrees C. / 510+ degrees F. Flash point: greater than 193 degrees C. / 380 degrees F. Evaporation rate: less than 1 (BUAC=1) Flammability (solid): not available Explosion limits: not available Vapor pressure: less than 1 (mmHg.) Vapor density: 1+ (air = 1) Relative density: not available Solubility: Negligible Partition coefficient: not available Auto-ignition temperature: not available Decomposition temperature: not available 10. Stability and reactivity Chemical stability: Products are all stable Possibility of hazardous reaction: None are known Conditions to avoid: Extreme heat Materials to avoid: strong oxidants Hazardous decomposition products: flame 11. Toxicological information

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Not Classified, Based on Ingredients Acute Toxicity: not available Subchronic/chronic toxicity: not available 12. Ecological information N/D 13. Disposal considerations Dispose of waste in a sanitary landfill licensed to receive non-hazardous industrial waste. Product is suitable for burning in an enclosed, controlled burner for fuel value or disposal by supervised incineration. Such burning may be limited by local regulation. The product is suitable for processing at an appropriate government waste disposal facility. Use of the methods is subject to user compliance with applicable laws and regulations and consideration of product characteristics at time of disposal. 14. Transport information Keep in shipping box and/or original box for transportation. Marine pollutant: No Keep away from heat. 15. Regulatory information FDA registration no. 1818792 16. Date prepared: March 31, 2014 The information contained herein is accurate to the best of our knowledge. My company makes no warranty of any kind, express or implied, concerning the safe use of this material in your process or in combination with other substances.

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SAFETY DATA SHEET

PRODUCT ID: MEPIVACAINE HYDROCHLORIDE INJECTION

P405 – Store locked up Disposal P501 – Dispose of contents/container in accordance with local/provincial/federal regulations

WHMIS Regulatory Status: Not WHMIS-Controlled

SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS

Chemical Identity Concentration

(Percent weight/weight) CAS Number

Mepivacaine Hydrochloride 3 1722-62-9

SECTION 4: FIRST AID MEASURES

Inhalation: Remove patient from exposure.

Eye Contact: Flush eyes with plenty of water for at least 15 minutes while holding eyelids open. Get medical attention, if irritation persists.

Skin Contact: Remove contaminated clothing. Wash skin with soap and water

Ingestion: Get immediate medical attention. Do not induce vomiting unless instructed to do so by poison control or physician.

Injection: Get immediate medical attention.

Personal Protective Equipment for First Aid Responders:

Wear impermeable gloves to avoid skin contact (e.g. nitrile, natural rubber).

SECTION 5: FIRE FIGHTING MEASURES

Suitable extinguishing media: Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials

Hazardous Combustion Products: Not available

Special Protective Actions for Firefighters:

As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

SECTION 6: ACCIDENTAL RELEASE MEASURES

Personal precautions: Caution should be used to prevent against ingestion and contact with eyes. Wear safety glasses with side shields.

Environmental precautions: Prevent spills from entering sewers and watercourses. Cover drains.

Methods and materials for containment and cleaning up:

Clean up spills with normal procedures used for non-hazardous liquids. This can include: absorb spill with inert material, then place in a chemical waste container. Clean surface thoroughly with water to

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SAFETY DATA SHEET

PRODUCT ID: MEPIVACAINE HYDROCHLORIDE INJECTION

remove residual contamination.

SECTION 7: HANDLING AND STORAGE

Handling Procedures and Equipment: Caution should be used to prevent against ingestion and contact with eyes.

Handle with care to avoid breakage.

Storage Requirements: Store in a cool, dry place. Avoid extremes in temperature.

Packaging: USP Type 1 glass with rubber stopper and cap

Sensitivity to Mechanical Impact: No

Sensitivity to Static Discharge: No

SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION

Exposure Limits: Chemical

Agent

Occupational Exposure Limits (OEL)

ACGIHa Ontario

TWAb STELc TWAb STELc

Mepivacaine Hydrochloride Not available Not available Not available Not available

a – American Conference of Governmental Industrial Hygienists b – Time Weighted Average c - Short-term Exposure Limit

Personal Protective Equipment (PPE):

Gloves (specify): Not normally required

Respiratory (specify): Not normally required

Eye (specify): Not normally required

Footwear (specify): Not normally required

Other Equipment (specify): RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE AVAILABLE DURING DENTAL PROCEDURES

Engineering Controls (e.g. ventilation, enclosed process, specify):

Not normally required

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Liquid

Odour and Appearance: Clear and odourless

Odour Threshold: Not applicable

Specific Gravity (water=1): 1

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SAFETY DATA SHEET

PRODUCT ID: MEPIVACAINE HYDROCHLORIDE INJECTION

Solubility in Water Soluble

Co-efficient of Water/Oil Distribution: Not available

Vapour Pressure: 17 mm Hg @ 20°C

Boiling Point (C): 100°C

Melting/Freezing Point (C): 0°C

pH: Not available

Vapour Density (Air=1): 0.6

Evaporation Rate (Butyl Acetate=1): 1

Flashpoint (C) and Method: Not flammable (water based)

Upper Flammable Limit (%): Not available

Lower Flammable Limit (%): Not available

Auto-ignition Temperature (C): Not available

Decomposition Temperature (C): Not available

SECTION 10: STABILITY AND REACTIVITY

Stability: Stable

Incompatible Materials: Incompatible with compounds which react violently with water

Conditions of Reactivity: None

Hazardous Decomposition Products: None

SECTION 11: TOXICOLOGICAL INFORMATION

Route of Entry: Skin Contact Skin Absorption Eye Contact Inhalation

Ingestion

Acute Toxicity: Not expected to be acutely toxic.

Acute measures of toxicity (i.e. LD50 and LC50) are not available for this mixture.

LD50 for Mepivacaine Hydrochloride: 310 mg/kg oral mouse

Skin Corrosion/Irritation: May be irritating to the skin.

Serious Eye Damage/Irritation: May be irritating to the eyes.

Respiratory or Skin Sensitization: Not available

Interactive Effects: Not available

Mutagenicity: Not available

Carcinogenicity: This product has not been listed as a carcinogen or a potential carcinogen by the ACGIH, the International Agency for Research on Cancer (IARC), the US National Toxicology Program (NTP) or the US

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SAFETY DATA SHEET

PRODUCT ID: MEPIVACAINE HYDROCHLORIDE INJECTION

Occupational Safety and Health Administration (OSHA).

Reproductive Toxicity: Evidence of human teratogenicity has been identified for this compound. Behavioral abnormalities have been reported in rats injected with mepivacaine.

Specific Target Organ Toxicity – Single Exposure:

Not available

Specific Target Organ Toxicity – Repeated Exposure:

May cause hypersensitivity. Associated with the development of methemoglobinemia.

Aspiration Hazard: Not available. Not expected to be of concern.

SECTION 12: ECOLOGICAL INFORMATION

Ecotoxicity: Not available

Persistence / Degradability: Not available

Bioaccumulation / Accumulation: Not available

Mobility in Environmental Media: Not available

Other Adverse Effects: Not available

SECTION 13: DISPOSAL CONSIDERATIONS

Disposal: Observe all Federal/Provincial/State and Local disposal regulations.

SECTION 14: TRANSPORTATION INFORMATION

Basic Shipping Description: Not available

Additional Information: Not available

Special Precautions: Avoid temperature extremes. Prevent from freezing.

UN Number: Not available

UN Proper Shipping Name: Not available

Transport Hazard Classes: Not available

Packing Group: Not available

Environmental Hazards: Not available

Special Precautions for User: Avoid temperature extremes. Prevent from freezing.

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SAFETY DATA SHEET

PRODUCT ID: MEPIVACAINE HYDROCHLORIDE INJECTION

SECTION 15: REGULATORY INFORMATION

This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all the information required by the Controlled Products Regulations.

OSHA Regulatory Status: Not available

Regulatory Status: This product is exempt from WHMIS as a drug product

SECTION 16: OTHER INFORMATION

Name of person or group that prepared MSDS:

Novocol Pharmaceutical in conjunction with a third party consultant

Phone #: 519-623-4800

MSDS Version#: # 4 (replaces V.3 of August 15, 2010)

Information and statements contained in this document have been obtained from manufacturers, suppliers and recognized reference sources as provided to or obtained by Novocol Pharmaceutical of Canada, Inc. Novocol Pharmaceutical of Canada, Inc. believes the information to be reliable but expressly disclaims any liability for providing such information and toxicology to our customers.

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1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND THE COMPANY/UNDERTAKINGProduct Identifier

Material Name: GELFOAM(R) Sterile Powder

Trade Name: GELFOAM(R)Synonyms: Absorbable gelatin powder from absorbable gelatin sponge, USPChemical Family: Not applicable

Relevant Identified Uses of the Substance or Mixture and Uses Advised AgainstIntended Use: Medical device

Details of the Supplier of the Safety Data Sheet

2. HAZARDS IDENTIFICATION

Classification of the Substance or MixtureGHS - Classification Not classified as hazardous

US OSHA Specific - Classification

Physical Hazard: Combustible DustEU Classification:

EU Indication of danger: Not classified

Label Elements

Signal Word: WarningHazard Statements: May form combustible dust concentrations in air

Other Hazards No data availableAustralian Hazard Classification(NOHSC):

Non-Hazardous Substance. Non-Dangerous Goods.

Note: This document has been prepared in accordance with standards for workplace safety, whichrequires the inclusion of all known hazards of the product or its ingredients regardless of thepotential risk. The precautionary statements and warning included may not apply in all cases.Your needs may vary depending upon the potential for exposure in your workplace.

_______________________________________________________________________________________________________PZ01349

Revision date: 10-Mar-2015

Pfizer Global SupplyPfizer Inc235 East 42nd StreetNew York, NY 100171-800-879-3477

Pfizer LtdRamsgate RoadSandwich, KentCT13 9NJUnited Kingdom+00 44 (0)1304 616161

Version: 2.0

Emergency telephone number:CHEMTREC (24 hours): 1-800-424-9300

SAFETY DATA SHEET

Emergency telephone number:International CHEMTREC (24 hours): +1-703-527-3887

Page 1 of 6

Contact E-Mail: [email protected]

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SAFETY DATA SHEET

_______________________________________________________________________________________________________

3. COMPOSITION / INFORMATION ON INGREDIENTS

Ingredient CAS Number EUEINECS/ELINCS

List

EU Classification GHSClassification

%

Water for injection 7732-18-5 231-791-2 Not Listed Not Listed *Gelatin 9000-70-8 232-554-6 Not Listed Not Listed *

Additional Information: * ProprietaryIngredient(s) indicated as hazardous have been assessed under standards for workplacesafety.In accordance with 29 CFR 1910.1200, the exact percentage composition of this mixture hasbeen withheld as a trade secret.

4. FIRST AID MEASURES

Description of First Aid MeasuresEye Contact: Flush eye(s) immediately with plenty of water. If irritation occurs or persists, get medical

attention.

Skin Contact: Wash skin with soap and water. If irritation occurs or persists, get medical attention.

Ingestion: Consult a physician if necessary

Inhalation: Due to the nature of this material first aid is not normally required. If discomfort occurs, getmedical attention.

Most Important Symptoms and Effects, Both Acute and DelayedSymptoms and Effects ofExposure:

No data available

Medical ConditionsAggravated by Exposure:

None known

Indication of the Immediate Medical Attention and Special Treatment NeededNotes to Physician: None

5. FIRE FIGHTING MEASURES

Extinguishing Media: Extinguish fires with CO2, extinguishing powder, foam, or water.

Special Hazards Arising from the Substance or MixtureHazardous CombustionProducts:

Formation of toxic gases is possible during heating or fire. May include oxides of carbon.

Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.

Advice for Fire-FightersDuring all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.

6. ACCIDENTAL RELEASE MEASURES

Personal Precautions, Protective Equipment and Emergency ProceduresPersonnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

Environmental Precautions

_______________________________________________________________________________________________________PZ01349

Revision date: 10-Mar-2015Material Name: GELFOAM(R) Sterile Powder

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SAFETY DATA SHEET

_______________________________________________________________________________________________________

Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Methods and Material for Containment and Cleaning UpMeasures for Cleaning /Collecting:

Contain the source of spill if it is safe to do so. Collect spilled material by a method thatcontrols dust generation. A damp cloth or a filtered vacuum should be used to clean spills ofdry solids. Clean spill area thoroughly.

Additional Consideration forLarge Spills:

Non-essential personnel should be evacuated from affected area. Report emergencysituations immediately. Clean up operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

Precautions for Safe HandlingNo special handling requirements for normal use of this material. Avoid generating airborne dust.

Conditions for Safe Storage, Including any IncompatibilitiesStorage Conditions: Store at room temperature in properly labeled containers. Keep away from heat, sparks and

flames.Specific end use(s): Medical device

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Control ParametersNo Occupational Exposure Limit (OEL) or Short Term Exposure Limit (STEL) has been identified.

Exposure ControlsEngineering Controls: General room ventilation is adequate unless the process generates dust, mist or fumes.Personal ProtectiveEquipment:

Refer to applicable national standards and regulations in the selection and use of personalprotective equipment (PPE).

Hands: Wear impervious gloves.Eyes: Not required under normal conditions of use.Skin: Wear protective clothing when working with large quantities.Respiratory protection: Under normal conditions of use, respiratory protection is not expected to be necessary.

Whenever air contamination (mist, vapor or odor) is generated, respiratory protection isrecommended as a precaution to minimize exposure.

9. PHYSICAL AND CHEMICAL PROPERTIES

Solvent Solubility: No data availableWater Solubility: No data availablepH: No data available.Melting/Freezing Point (°C): No data availableBoiling Point (°C): No data available.Partition Coefficient: (Method, pH, Endpoint, Value)

Decomposition Temperature (°C): No data available.

Evaporation Rate (Gram/s): No data available_______________________________________________________________________________________________________

PZ01349

Material Name: GELFOAM(R) Sterile Powder

Molecular Formula: Mixture

GelatinNo data available

Molecular Weight: Mixture

Water for injection

Version: 2.0

No data available

Physical State: Solid

Page 3 of 6

Color: No data available.Odor: No data available.

Revision date: 10-Mar-2015

Odor Threshold: No data available.

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SAFETY DATA SHEET

_______________________________________________________________________________________________________

Vapor Pressure (kPa): No data availableVapor Density (g/ml): No data availableRelative Density: No data availableViscosity: No data available

Flammablity:Autoignition Temperature (Solid) (°C): No data availableFlammability (Solids): No data availableFlash Point (Liquid) (°C): No data availableUpper Explosive Limits (Liquid) (% by Vol.): No data availableLower Explosive Limits (Liquid) (% by Vol.): No data available

10. STABILITY AND REACTIVITY

Reactivity: No data availableChemical Stability: Stable under normal conditions of use.Possibility of Hazardous Reactions

Oxidizing Properties: No data availableConditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.Incompatible Materials: As a precautionary measure, keep away from strong oxidizersHazardous DecompositionProducts:

No data available

11. TOXICOLOGICAL INFORMATION

Information on Toxicological EffectsGeneral Information: This product is composed of non-hazardous ingredients.

Carcinogen Status: Not listed as a carcinogen by IARC, NTP or US OSHA.

12. ECOLOGICAL INFORMATION

Environmental Overview: Environmental properties have not been investigated. Releases to the environment should beavoided.

Toxicity: No data available

Persistence and Degradability: No data available

Bio-accumulative Potential: No data available

Mobility in Soil: No data available

_______________________________________________________________________________________________________PZ01349

Version: 2.0Page 4 of 6

Revision date: 10-Mar-2015Material Name: GELFOAM(R) Sterile Powder

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SAFETY DATA SHEET

_______________________________________________________________________________________________________

13. DISPOSAL CONSIDERATIONS

Waste Treatment Methods: Dispose of waste in accordance with all applicable laws and regulations. Member Statespecific and Community specific provisions must be considered. Considering the relevantknown environmental and human health hazards of the material, review and implementappropriate technical and procedural waste water and waste disposal measures to preventoccupational exposure and environmental release. It is recommended that waste minimizationbe practiced. The best available technology should be utilized to prevent environmentalreleases. This may include destructive techniques for waste and wastewater.

14. TRANSPORT INFORMATION

The following refers to all modes of transportation unless specified below.

Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

15. REGULATORY INFORMATION

Safety, Health and Environmental Regulations/Legislation Specific for the Substance or Mixture

Canada - WHMIS: ClassificationsWHMIS hazard class:None requiredThis product has been classified in accordance with the hazard criteria of the CPR and the MSDS contains all of the informationrequired by the CPR.

_______________________________________________________________________________________________________PZ01349

REACH - Annex IV - Exemptions from theobligations of Register:

Present

Material Name: GELFOAM(R) Sterile Powder

EU EINECS/ELINCS List 231-791-2

CERCLA/SARA 313 Emission reporting

Gelatin

Not Listed

CERCLA/SARA 313 Emission reporting Not Listed

Version: 2.0

California Proposition 65 Not Listed

California Proposition 65 Not Listed

Inventory - United States TSCA - Sect. 8(b) Present

Page 5 of 6

Australia (AICS): PresentEU EINECS/ELINCS List 232-554-6

Inventory - United States TSCA - Sect. 8(b) Present

Revision date: 10-Mar-2015

Australia (AICS): Present

Water for injection

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SAFETY DATA SHEET

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16. OTHER INFORMATION

Data Sources: Pfizer proprietary drug development information.

Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 7 - Handling and Storage.

Revision date: 10-Mar-2015

Prepared by:Product Stewardship Hazard Communication

Pfizer Global Environment, Health, and Safety Operations

Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, itis without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no knowninformation at this time.

End of Safety Data Sheet

_______________________________________________________________________________________________________PZ01349

Material Name: GELFOAM(R) Sterile PowderVersion: 2.0Page 6 of 6

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SAFETY DATA SHEET

PRODUCT ID: ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION

SECTION 1: IDENTIFICATION

Product Name: Articaine Hydrochloride 4% and Epinephrine 1:100,000 Injection

Articaine Hydrochloride 4% and Epinephrine 1:200,000 Injection

Brand Name: SEPTANEST SP® (Articaine Hydrochloride 4% and Epinephrine 1:100,000; Injection)

SEPTANEST N® (Articaine Hydrochloride 4% and Epinephrine 1:200,000; Injection)

SEPTOCAINE ® (Articaine Hydrochloride 4% and Epinephrine 1:100,000 and 1:200,000; Injection)

POSICAINE ® (Articaine Hydrochloride 4% and Epinephrine 1:100,000 and 1:200,000; Injection)

Manufacturer / Supplier: Septodont P. O. Box 68 Cambridge, Ontario, Canada N1R 5S9 519-623-4800 http://www.septodont.ca/

Prepared By: Septodont in conjunction with a third party consultant

Emergency Phone Number: 1-519-623-4800 (Monday-Friday 08:30 to 16:30)

Product Use: Local anesthetic solution for use in peripheral nerve blocks

Date of Preparation: July 19, 2013

SECTION 2: HAZARD IDENTIFICATION

Classification: Narcotic effects, Category 3

GHS Label Symbol:

Hazard Statements: Warning H336 - May cause drowsiness or dizziness

May cause skin and/or eye irritation

Causes central nervous system effects such as drowsiness, confusion, excitability and nervousness. Acts as a depressant on the cardiovascular system.

Avoid use in individuals with hypersensitivities to amide-type anesthetics. Use with caution in individuals with diabetes and/or severe hypertension.

CONSULT PRODUCT INSERT FOR CLINICAL AND PHARMACOPIAL INFORMATION

Signs and Symptoms of Overexposure: Drowsiness, confusion, excitability, nervousness, drop in blood pressure, fatigue, bluish discoloration of fingernails, lips, or skin, difficulties in breathing.

Page 1 of 6

~Verified on 2014-07 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-07. ~

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SAFETY DATA SHEET

PRODUCT ID: ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION

Precautionary Statements: Prevention

P261 – Do not breathe mist/vapours/spray P271 – Use in a well-ventilated area Response P304+P430 – If inhaled – remove victim to fresh air and keep at rest in a position comfortable for breathing P312 – Call a POISON CENTER or doctor/physician if you feel unwell Storage P405 – Store locked up Disposal P501 – Dispose of contents/container in accordance with local/provincial/federal regulations

WHMIS Regulatory Status: Not WHMIS-Controlled

SECTION 3: COMPOSITION / INFORMATION ON INGREDIENTS

Chemical Identity Concentration

(Percent weight/weight) CAS Number

Articaine Hydrochloride 4 23964-57-0

Epinephrine 0.0005 - 0.001 51-43-4

SECTION 4: FIRST AID MEASURES

Inhalation: Remove patient from exposure.

Eye Contact: Flush eyes with plenty of water for at least 15 minutes while holding eyelids open. Get medical attention, if irritation persists.

Skin Contact: Remove contaminated clothing. Wash skin with soap and water

Ingestion: Get immediate medical attention. Do not induce vomiting unless instructed to do so by poison control or physician.

Personal Protective Equipment for First Aid Responders:

Wear impermeable gloves to avoid skin contact (e.g. nitrile, natural rubber).

SECTION 5: FIRE FIGHTING MEASURES

Suitable extinguishing media: Water spray, dry chemical, carbon dioxide, or foam as appropriate for surrounding fire and materials

Hazardous Combustion Products: Not available

Special Protective Actions for Firefighters:

As with all fires, evacuate personnel to a safe area. Firefighters should use self-contained breathing equipment and protective clothing.

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SAFETY DATA SHEET

PRODUCT ID: ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION

SECTION 6: ACCIDENTAL RELEASE MEASURES

Personal precautions: Caution should be used to prevent against ingestion and contact with eyes. Wear safety glasses with side shields.

Environmental precautions: Prevent spills from entering sewers and watercourses. Cover drains.

Methods and materials for containment and cleaning up:

Clean up spills with normal procedures used for non-hazardous liquids. This can include: absorb spill with inert material, then place in a chemical waste container. Clean surface thoroughly with water to remove residual contamination.

SECTION 7: HANDLING AND STORAGE

Handling Procedures and Equipment: Caution should be used to prevent against ingestion and contact with eyes.

Handle with care to avoid breakage.

Storage Requirements: Store in a cool, dry place. Avoid extremes in temperature.

Packaging: USP Type 1 glass with rubber stopper and cap

Sensitivity to Mechanical Impact: No

Sensitivity to Static Discharge: No

SECTION 8: EXPOSURE CONTROLS / PERSONAL PROTECTION

Exposure Limits: Chemical

Agent

Occupational Exposure Limits (OEL)

ACGIHa Ontario

TWAb STELc TWAb STELc

Articaine Hydrochloride Not available Not available Not available Not available

Epinephrine Not available Not available Not available Not available

a – American Conference of Governmental Industrial Hygienists b – Time Weighted Average c - Short-term Exposure Limit

Personal Protective Equipment (PPE):

Gloves (specify): Not normally required

Respiratory (specify): Not normally required

Eye (specify): Not normally required

Footwear (specify): Not normally required

Other Equipment (specify): RESUSCITATIVE EQUIPMENT AND DRUGS SHOULD BE AVAILABLE DURING DENTAL PROCEDURES

Engineering Controls (e.g. ventilation, enclosed process, specify):

Not normally required

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SAFETY DATA SHEET

PRODUCT ID: ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

Physical State: Liquid

Odour and Appearance: Clear and odourless

Odour Threshold: Not applicable

Specific Gravity (water=1): 1

Solubility in Water Soluble

Co-efficient of Water/Oil Distribution: Not available

Vapour Pressure: 17 mm Hg @ 20°C

Boiling Point (C): 100°C

Melting/Freezing Point (C): 0°C

pH: Not available

Vapour Density (Air=1): 0.6

Evaporation Rate (Butyl Acetate=1): 1

Flashpoint (C) and Method: Not flammable (water based)

Upper Flammable Limit (%): Not available

Lower Flammable Limit (%): Not available

Auto-ignition Temperature (C): Not available

Decomposition Temperature (C): Not available

SECTION 10: STABILITY AND REACTIVITY

Reactivity: Stable

Chemical Stability: Stable

Conditions to Avoid: None

Incompatible Materials: Incompatible with compounds which react violently with water

Hazardous Decomposition Products: None

SECTION 11: TOXICOLOGICAL INFORMATION

Route of Entry: Skin Contact Skin Absorption Eye Contact Inhalation

Ingestion

Acute Toxicity: Not expected to be acutely toxic.

Acute measures of toxicity (i.e. LD50 and LC50) are not available for this mixture.

Page 4 of 6

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SAFETY DATA SHEET

PRODUCT ID: ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION

LD50 for Articaine Hydrochloride: 980 mg/kg oral rat

LD50 for Epinephrine: 5 mg/kg dermal rat

Skin Corrosion/Irritation: May be irritating to the skin.

Serious Eye Damage/Irritation: May be irritating to the eyes.

Respiratory or Skin Sensitization: Not available

Interactive Effects: Not available

Mutagenicity: Not available

Carcinogenicity: This product has not been listed as a carcinogen or a potential carcinogen by the ACGIH, the International Agency for Research on Cancer (IARC), the US National Toxicology Program (NTP) or the US Occupational Safety and Health Administration (OSHA).

Reproductive Toxicity: Animal studies have reported the increased incidence of stillbirths, skeletal abnormalities and delayed neurological development, but only at levels that were toxic to the mother.

Specific Target Organ Toxicity – Single Exposure:

Not available

Specific Target Organ Toxicity – Repeated Exposure:

May cause hypersensitivity. Associated with the development of methemoglobinemia.

Aspiration Hazard: Not available. Not expected to be of concern.

SECTION 12: ECOLOGICAL INFORMATION

Ecotoxicity: Not available

Persistence / Degradability: Not available

Bioaccumulation / Accumulation: Not available

Mobility in Environmental Media: Not available

Other Adverse Effects: Not available

SECTION 13: DISPOSAL CONSIDERATIONS

Disposal: Observe all Federal/Provincial/State and Local disposal regulations.

SECTION 14: TRANSPORTATION INFORMATION

UN Number: Not available

UN Proper Shipping Name: Not available

Transport Hazard Classes: Not available

Page 5 of 6

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SAFETY DATA SHEET

PRODUCT ID: ARTICAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION

Packing Group: Not available

Environmental Hazards: Not available

Special Precautions for User: Avoid temperature extremes. Prevent from freezing.

SECTION 15: REGULATORY INFORMATION

This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all the information required by the Controlled Products Regulations.

OSHA Regulatory Status: Epinephrine is listed as a hazardous product in the RCRA (EPA) and CERCLA (EPA) regulations.

Regulatory Status: This product is exempt from WHMIS as a drug product

SECTION 16: OTHER INFORMATION

Name of person or group that prepared MSDS:

Septodont in conjunction with a third party consultant

Phone #: 519-623-4800

MSDS Version#: # 4 (replaces V.3 of August 15, 2010)

Information and statements contained in this document have been obtained from manufacturers, suppliers and recognized reference sources as provided to or obtained by Septodont. Septodont believes the information to be reliable but expressly disclaims any liability for providing such information and toxicology to our customers.

Novocol Pharmaceutical of Canada, Inc. doing business as Septodont

Page 6 of 6

~Verified on 2014-07 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-07. ~

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40.1.1

1 Identification· Product identifier· Trade name: EQUIA® Fil (Liquid)· Relevant identified uses of the substance or mixture and uses advised againstDental materialThe product is intended for professional use.To avoid risks for humans and environment obtain instructions.

· Application of the substance / the mixture Dental filling material· Details of the supplier of the safety data sheet· Manufacturer/Supplier:GC America Inc.3737 W. 127th StreetAlsip, IL 60803USA

[email protected]· Information department: Regulatory Affairs· Emergency telephone number:During normal opening times (Mon.-Fri. 8:00 AM-5:00 PM CST): +1 (708) 597-0900Transportation (CHEMTREC®) Emergency Telephone No. +1 (800) 424-9300

2 Hazard(s) identification· Classification of the substance or mixtureSkin Corr. 1A H314 Causes severe skin burns and eye damage.Eye Dam. 1 H318 Causes serious eye damage.

· Additional information:The information provided is in regards to the toxicity and hazard rating(s) of the individual component(s)in the formulation. The associated risk(s) depends on the route(s) of exposure. The hazard ratingsystem is based entirely on the existence of the risk(s) and does not take into account the likelihood ofreduced risk(s) through proper usage and handling.

· Label elements· GHS label elementsThe product is classified and labeled according to the Globally Harmonized System (GHS).

· Hazard pictograms

~GHS05

· Signal word Danger· Hazard-determining components of labeling:polybasic carboxylic acid**

· Hazard statementsCauses severe skin burns and eye damage.

(Contd. on page 2) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 1)

40.1.1

· Precautionary statementsDo not breathe dusts or mists.Wear eye protection / face protection.If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.Immediately call a poison center/doctor.Store locked up.Dispose of contents/container in accordance with local/regional/national/international regulations.

· Classification system:· NFPA ratings (scale 0 - 4)

20

0Health = 2Fire = 0Reactivity = 0

· HMIS-ratings (scale 0 - 4) HEALTH

FIRE

REACTIVITY

2

0

0

Health = 2Fire = 0Reactivity = 0

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

3 Composition/information on ingredients· Chemical characterization: Mixtures· Description: Mixture of the substances listed below with nonhazardous additions.· Dangerous components:polybasic carboxylic acid** 5-10%

· Additional information:If a substance is marked with **, then substance is a trade secret. This is allowed under OSHA’sHazard Communication Standard (HCS) as a trade secret and under GHS as Confidential BusinessInformation (CBI).

4 First-aid measures· Description of first aid measures· General information:Immediately remove any clothing soiled by the product.If symptoms persist consult doctor.

· After inhalation:Supply fresh air; consult doctor in case of complaints.In case of unconsciousness place patient stably in side position for transportation.

· After skin contact:Immediately wash with water and soap and rinse thoroughly.Seek medical treatment.

(Contd. on page 3) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 2)

40.1.1

· After eye contact:Protect unharmed eye.Rinse opened eye for several minutes under running water.Call a doctor immediately.

· After swallowing:Rinse out mouth and then drink plenty of water.If symptoms persist consult doctor.

· Information for doctor:· Most important symptoms and effects, both acute and delayedNo further relevant information available.

· Indication of any immediate medical attention and special treatment neededNo further relevant information available.

5 Fire-fighting measures· Extinguishing media· Suitable extinguishing agents:CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.Use fire fighting measures that suit the environment.

· For safety reasons unsuitable extinguishing agents: Water with full jet· Special hazards arising from the substance or mixtureFormation of toxic gases is possible during heating or in case of fire.

· Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.· Additional informationDispose of fire debris and contaminated fire fighting water in accordance with official regulations.

6 Accidental release measures· Personal precautions, protective equipment and emergency proceduresRemove persons from danger area.Avoid contact with the eyes and skin.Wear protective clothing.

· Environmental precautions:Do not allow product to reach sewage system or any water course.Do not allow to penetrate the ground/soil.

· Methods and material for containment and cleaning up:Use neutralizing agent.Absorb liquid components with liquid-binding material.Dispose of the collected material according to regulations.

· Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7 Handling and storage· Handling:· Precautions for safe handlingObserve instructions for use.

(Contd. on page 4) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 3)

40.1.1

Ensure good ventilation/exhaustion at the workplace.Prevent formation of aerosols.Avoid contact with the eyes and skin.

· Information about protection against explosions and fires: No special measures required.· Storage:· Requirements to be met by storerooms and receptacles:Store only in unopened original receptacles.

· Information about storage in one common storage facility: Store away from foodstuffs.· Further information about storage conditions:Observe instructions for use / storage.Keep receptacle tightly sealed.

· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection· Additional information about design of technical systems: No further data; see item 7.· Control parameters· Components with limit values that require monitoring at the workplace:The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.

· Additional information: The lists that were valid during the creation were used as basis.· Exposure controls· Personal protective equipment:· General protective and hygienic measures:The usual precautionary measures for handling chemicals should be followed.Avoid contact with the eyes and skin.Wash hands before breaks and at the end of work.Keep away from foodstuffs, beverages and feed.Immediately remove all soiled and contaminated clothing.

· Breathing equipment: Suitable respiratory protective device recommended.· Protection of hands: Protective gloves· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks ofquality and varies from manufacturer to manufacturer. As the product is a preparation of severalsubstances, the resistance of the glove material can not be calculated in advance and has therefore tobe checked prior to the application.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and hasto be observed.

· Eye protection: Safety glasses

9 Physical and chemical properties· Information on basic physical and chemical properties· General Information· Appearance:

Form: LiquidColor: Light yellow

(Contd. on page 5) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 4)

40.1.1

· Odor: Odorless· Odor threshold: Not determined.· pH-value at 20 °C (68 °F): 1.9· Change in condition

Melting point/Melting range: Undetermined.Boiling point/Boiling range: Undetermined.

· Flash point: Not applicable.· Flammability (solid, gaseous): Not applicable.· Ignition temperature: Undetermined.· Decomposition temperature: Not determined.· Auto igniting: Product is not selfigniting.· Danger of explosion: Product does not present an explosion hazard.· Explosion limits:

Lower: Not determined.Upper: Not determined.

· Vapor pressure: Not determined.· Density: Not determined.· Relative density Not determined.· Vapour density Not determined.· Evaporation rate Not determined.· Solubility in / Miscibility with

Water: Insoluble.· Partition coefficient (n-octanol/water): Not determined.· Viscosity:

Dynamic: Not determined.Kinematic: Not determined.

· Solvent content:Organic solvents: 0.0 %Water: 52.0 %

Solids content: 48.0 %· Other information No further relevant information available.

10 Stability and reactivity· Reactivity No further relevant information available.· Chemical stability Stable at ambient temperature.· Thermal decomposition / conditions to be avoided:No decomposition if used according to specifications.

· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid No further relevant information available.· Incompatible materials: No further relevant information available.

(Contd. on page 6) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 5)

40.1.1

· Hazardous decomposition products: No dangerous decomposition products known.

11 Toxicological information· Information on toxicological effects· Acute toxicity:· LD/LC50 values that are relevant for classification: No further relevant information available.· Primary irritant effect:· on the skin: Strong caustic effect on skin and mucous membranes.· on the eye:Strong caustic effect.Strong irritant with the danger of severe eye injury.

· Sensitization: No sensitizing effects known.· Additional toxicological information:The product shows the following dangers according to internally approved calculation methods forpreparations:Corrosive

· Carcinogenic categories· IARC (International Agency for Research on Cancer)poly(acrylic acid) 3

· NTP (National Toxicology Program)None of the ingredients is listed.

· OSHA-Ca (Occupational Safety & Health Administration)None of the ingredients is listed.

· Carcinogenic categories' legend:IARC Group 1: The agent is carcinogenic to humans.IARC Group 2A: The agent is probably carcinogenic to humans.IARC Group 2B: The agent is possibly carcinogenic to humans.IARC Group 3: The agent is not classifiable as to its carcinogenicity to humans.IARC Group 4: The agent is probably not carcinogenic to humans.NTP K: Known to be human carcinogen.NTP R: Reasonably anticipated to be human carcinogen.

12 Ecological information· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes:Water hazard class 1 (Self-assessment): slightly hazardous for waterDo not allow undiluted product or large quantities of it to reach ground water, water course or sewagesystem.Must not reach bodies of water or drainage ditch undiluted or unneutralized.Rinse off of bigger amounts into drains or the aquatic environment may lead to decreased pH-values. Alow pH-value harms aquatic organisms. In the dilution of the use-level the pH-value is considerablyincreased, so that after the use of the product the aqueous waste, emptied into drains, is only low

(Contd. on page 7) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 6)

40.1.1

water-dangerous.· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

13 Disposal considerations· Waste treatment methods· Recommendation:Must not be disposed of together with household garbage. Do not allow product to reach sewagesystem.

· Uncleaned packagings:· Recommendation: Disposal must be made according to official regulations.

14 Transport information· UN-Number· DOT, ADR, ADN, IMDG, IATA Void· UN proper shipping name· DOT, ADR, ADN, IMDG, IATA Void· Transport hazard class(es)· DOT, ADR, ADN, IMDG, IATA· Class Void· Packing group· DOT, ADR, IMDG, IATA Void· Environmental hazards:· Marine pollutant: No· Special precautions for user Not applicable.· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

· UN "Model Regulation": -

15 Regulatory information· Safety, health and environmental regulations/legislation specific for the substance or mixture· SARA (Superfund Amendments and Reauthorization Act)· Section 355 (extremely hazardous substances):None of the ingredient is listed.

· Section 313 (Specific toxic chemical listings):None of the ingredients is listed.

(Contd. on page 8) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 7)

40.1.1

· TSCA (Toxic Substances Control Act):All ingredients are listed.

· Carcinogenic categories· EPA (Environmental Protection Agency)None of the ingredients is listed.

· TLV (Threshold Limit Value established by ACGIH)None of the ingredients is listed.

· NIOSH-Ca (National Institute for Occupational Safety and Health)None of the ingredients is listed.

· GHS label elementsThe product is classified and labeled according to the Globally Harmonized System (GHS).

· Hazard pictograms

~GHS05

· Signal word Danger· Hazard-determining components of labeling:polybasic carboxylic acid**

· Hazard statementsCauses severe skin burns and eye damage.

· Precautionary statementsDo not breathe dusts or mists.Wear eye protection / face protection.If on skin (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower.If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easyto do. Continue rinsing.Immediately call a poison center/doctor.Store locked up.Dispose of contents/container in accordance with local/regional/national/international regulations.

· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information· Department issuing MSDS: Regulatory Affairs· Contact:Regulatory AffairsTelephone No. +1 (708) [email protected]

· Date of preparation / last revision 02/24/2015 / -· Abbreviations and acronyms:

GHS: Globally Harmonized System of Classification and Labelling of ChemicalsHCS: Hazard Communication Standard (USA)MSDS: Material Safety Data SheetSDS: Safety Data SheetADN: Accord européen relatif au transport international des marchandises dangereuses par voies de navigation intérieures(European Agreement Concerning the International Carriage of Dangerous Goods by Inland Waterways)ECHA: European Chemicals Agency

(Contd. on page 9) USA

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Trade name: EQUIA® Fil (Liquid)

(Contd. of page 8)

40.1.1

OSHA: Occupational Safety and Health Administration (USA)ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning theInternational Carriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)HMIS: Hazardous Materials Identification System (USA)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very BioaccumulativeSkin Corr. 1A: Skin corrosion/irritation, Hazard Category 1AEye Dam. 1: Serious eye damage/eye irritation, Hazard Category 1

· Sources• Manufacturers' MSDSs/SDSs• OSHA (https://www.osha.gov/dts/chemicalsampling/toc/chmcas.html)• TOXNET (http://toxnet.nlm.nih.gov/)• ECHA (http://echa.europa.eu/)• EnviChem (www.echemportal.org)

· Notes:CAS Registry Number is a Registered Trademark of the American Chemical Society.CHEMTREC® is a registered service mark of the American Chemistry Council, Inc.

· * Data compared to the previous version altered. This version replaces all previous versions.· Disclaimer:The information contained herein is believed to be true and accurate. However, all statements,recommendations or suggestions are made without any guarantee, representation or warranty, expressor implied, on our part. Therefore, no warranty is made or to be implied that the information set out inthis document is accurate or complete, and we accordingly exclude all liability in connection with the useof this information or the products referred to herein. All such risks are assumed by the purchaser/user.The information contained herein is also subject to change without notice. For the avoidance of doubt,however, nothing in this document excludes or limits our liability for death or personal injury caused byour negligence or for fraudulent misrepresentation.

USA

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40.1.1

1 Identification· Product identifier· Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)· Relevant identified uses of the substance or mixture and uses advised againstDental materialThe product is intended for professional use.To avoid risks for humans and environment obtain instructions.

· Application of the substance / the mixture Dental filling material· Details of the supplier of the safety data sheet· Manufacturer/Supplier:GC America Inc.3737 W. 127th StreetAlsip, IL 60803USA

[email protected]· Information department: Regulatory Affairs· Emergency telephone number:During normal opening times (Mon.-Fri. 8:00 AM-5:00 PM CST): +1 (708) 597-0900Transportation (CHEMTREC®) Emergency Telephone No. +1 (800) 424-9300

2 Hazard(s) identification· Classification of the substance or mixtureThe product is not classified according to the Globally Harmonized System (GHS).

· Additional information:The information provided is in regards to the toxicity and hazard rating(s) of the individual component(s)in the formulation. The associated risk(s) depends on the route(s) of exposure. The hazard ratingsystem is based entirely on the existence of the risk(s) and does not take into account the likelihood ofreduced risk(s) through proper usage and handling.

· Label elements· GHS label elements Void· Hazard pictograms Void· Signal word Void· Hazard statements Void· Classification system:· NFPA ratings (scale 0 - 4)

00

0Health = 0Fire = 0Reactivity = 0

· HMIS-ratings (scale 0 - 4) HEALTH

FIRE

REACTIVITY

0

0

0

Health = 0Fire = 0Reactivity = 0

(Contd. on page 2) USA

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Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)

(Contd. of page 1)

40.1.1

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

3 Composition/information on ingredients· Chemical characterization: Mixtures· Description: Mixture of the substances listed below with nonhazardous additions.· Dangerous components: Void· Additional information:If a substance is marked with **, then substance is a trade secret. This is allowed under OSHA’sHazard Communication Standard (HCS) as a trade secret and under GHS as Confidential BusinessInformation (CBI).

4 First-aid measures· Description of first aid measures· General information:No special measures required.If symptoms persist consult doctor.

· After inhalation:Supply fresh air; consult doctor in case of complaints.In case of unconsciousness place patient stably in side position for transportation.

· After skin contact:Generally the product does not irritate the skin.Rinse with warm water.If symptoms persist consult doctor.

· After eye contact:Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.

· After swallowing:Rinse out mouth and then drink plenty of water.If symptoms persist consult doctor.

· Information for doctor:· Most important symptoms and effects, both acute and delayedNo further relevant information available.

· Indication of any immediate medical attention and special treatment neededNo further relevant information available.

5 Fire-fighting measures· Extinguishing media· Suitable extinguishing agents:CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.Use fire fighting measures that suit the environment.

· For safety reasons unsuitable extinguishing agents: Water with full jet· Special hazards arising from the substance or mixtureFormation of toxic gases is possible during heating or in case of fire.

(Contd. on page 3) USA

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Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)

(Contd. of page 2)

40.1.1

· Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.· Additional informationDispose of fire debris and contaminated fire fighting water in accordance with official regulations.

6 Accidental release measures· Personal precautions, protective equipment and emergency proceduresRemove persons from danger area.

· Environmental precautions:Do not allow product to reach sewage system or any water course.Do not allow to penetrate the ground/soil.

· Methods and material for containment and cleaning up:Pick up mechanically.Dispose of the collected material according to regulations.

· Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7 Handling and storage· Handling:· Precautions for safe handlingObserve instructions for use.Prevent formation of dust.Any deposit of dust which cannot be avoided must be regularly removed.

· Information about protection against explosions and fires:Dust can combine with air to form an explosive mixture.

· Storage:· Requirements to be met by storerooms and receptacles:Store only in unopened original receptacles.

· Information about storage in one common storage facility: Store away from foodstuffs.· Further information about storage conditions: Observe instructions for use / storage.· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection· Additional information about design of technical systems: No further data; see item 7.· Control parameters· Components with limit values that require monitoring at the workplace:The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.

· Additional information: The lists that were valid during the creation were used as basis.· Exposure controls· Personal protective equipment:· General protective and hygienic measures:The usual precautionary measures for handling chemicals should be followed.Do not inhale dust / smoke / mist.

(Contd. on page 4) USA

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acc. to OSHA HCS 29 CFR 1910.1200Printing date 02/24/2015 Reviewed on 02/24/2015Version US-EN-Rev 1

Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)

(Contd. of page 3)

40.1.1

Wash hands before breaks and at the end of work.· Breathing equipment: Suitable respiratory protective device recommended.· Protection of hands: Protective gloves· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks ofquality and varies from manufacturer to manufacturer. As the product is a preparation of severalsubstances, the resistance of the glove material can not be calculated in advance and has therefore tobe checked prior to the application.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and hasto be observed.

· Eye protection: Safety glasses

9 Physical and chemical properties· Information on basic physical and chemical properties· General Information· Appearance:

Form: PowderColor: According to product specification

· Odor: Odorless· Odor threshold: Not determined.· pH-value: Not applicable.· Change in condition

Melting point/Melting range: Undetermined.Boiling point/Boiling range: Undetermined.

· Flash point: Not applicable.· Flammability (solid, gaseous): Not determined.· Ignition temperature: Undetermined.· Decomposition temperature: Not determined.· Auto igniting: Product is not selfigniting.· Danger of explosion: Product does not present an explosion hazard.· Explosion limits:

Lower: Not determined.Upper: Not determined.

· Vapor pressure: Not applicable.· Density: Not determined.· Relative density Not determined.· Vapour density Not applicable.· Evaporation rate Not applicable.· Solubility in / Miscibility with

Water: Insoluble.· Partition coefficient (n-octanol/water): Not determined.

(Contd. on page 5) USA

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Page 5/8Safety Data Sheet

acc. to OSHA HCS 29 CFR 1910.1200Printing date 02/24/2015 Reviewed on 02/24/2015Version US-EN-Rev 1

Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)

(Contd. of page 4)

40.1.1

· Viscosity:Dynamic: Not applicable.Kinematic: Not applicable.

· Solvent content:Organic solvents: 0.0 %

Solids content: 100.0 %· Other information No further relevant information available.

10 Stability and reactivity· Reactivity No further relevant information available.· Chemical stability Stable at ambient temperature.· Thermal decomposition / conditions to be avoided:No decomposition if used according to specifications.

· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid No further relevant information available.· Incompatible materials: No further relevant information available.· Hazardous decomposition products: No dangerous decomposition products known.

11 Toxicological information· Information on toxicological effects· Acute toxicity:· LD/LC50 values that are relevant for classification: No further relevant information available.· Primary irritant effect:· on the skin: No irritant effect.· on the eye: No irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:The product is not subject to classification according to internally approved calculation methods forpreparations:

· Carcinogenic categories· IARC (International Agency for Research on Cancer)poly(acrylic acid) 3

· NTP (National Toxicology Program)None of the ingredients is listed.

· OSHA-Ca (Occupational Safety & Health Administration)None of the ingredients is listed.

· Carcinogenic categories' legend:(Contd. on page 6)

USA

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Page 6/8Safety Data Sheet

acc. to OSHA HCS 29 CFR 1910.1200Printing date 02/24/2015 Reviewed on 02/24/2015Version US-EN-Rev 1

Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)

(Contd. of page 5)

40.1.1

IARC Group 1: The agent is carcinogenic to humans.IARC Group 2A: The agent is probably carcinogenic to humans.IARC Group 2B: The agent is possibly carcinogenic to humans.IARC Group 3: The agent is not classifiable as to its carcinogenicity to humans.IARC Group 4: The agent is probably not carcinogenic to humans.NTP K: Known to be human carcinogen.NTP R: Reasonably anticipated to be human carcinogen.

12 Ecological information· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes:Water hazard class 1 (Self-assessment): slightly hazardous for waterDo not allow undiluted product or large quantities of it to reach ground water, water course or sewagesystem.

· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

13 Disposal considerations· Waste treatment methods· Recommendation: Smaller quantities can be disposed of with household waste.· Uncleaned packagings:· Recommendation: Disposal must be made according to official regulations.

14 Transport information· UN-Number· DOT, ADR, ADN, IMDG, IATA Void· UN proper shipping name· DOT, ADR, ADN, IMDG, IATA Void· Transport hazard class(es)· DOT, ADR, ADN, IMDG, IATA· Class Void· Packing group· DOT, ADR, IMDG, IATA Void

(Contd. on page 7) USA

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Page 7/8Safety Data Sheet

acc. to OSHA HCS 29 CFR 1910.1200Printing date 02/24/2015 Reviewed on 02/24/2015Version US-EN-Rev 1

Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)

(Contd. of page 6)

40.1.1

· Environmental hazards:· Marine pollutant: No· Special precautions for user Not applicable.· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

· UN "Model Regulation": -

15 Regulatory information· Safety, health and environmental regulations/legislation specific for the substance or mixture· SARA (Superfund Amendments and Reauthorization Act)· Section 355 (extremely hazardous substances):None of the ingredient is listed.

· Section 313 (Specific toxic chemical listings):None of the ingredients is listed.

· TSCA (Toxic Substances Control Act):glass, oxide, chemicalspoly(acrylic acid)

· Carcinogenic categories· EPA (Environmental Protection Agency)None of the ingredients is listed.

· TLV (Threshold Limit Value established by ACGIH)None of the ingredients is listed.

· NIOSH-Ca (National Institute for Occupational Safety and Health)None of the ingredients is listed.

· GHS label elements Void· Hazard pictograms Void· Signal word Void· Hazard statements Void· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information· Department issuing MSDS: Regulatory Affairs· Contact:Regulatory AffairsTelephone No. +1 (708) [email protected]

· Date of preparation / last revision 02/24/2015 / -· Abbreviations and acronyms:

GHS: Globally Harmonized System of Classification and Labelling of ChemicalsHCS: Hazard Communication Standard (USA)MSDS: Material Safety Data SheetSDS: Safety Data Sheet

(Contd. on page 8) USA

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Page 8/8Safety Data Sheet

acc. to OSHA HCS 29 CFR 1910.1200Printing date 02/24/2015 Reviewed on 02/24/2015Version US-EN-Rev 1

Trade name: EQUIA® Fil (Powder, Shades: A1, A2, A3, A3.5, B1, B2, B3, and C4)

(Contd. of page 7)

40.1.1

ADN: Accord européen relatif au transport international des marchandises dangereuses par voies de navigation intérieures(European Agreement Concerning the International Carriage of Dangerous Goods by Inland Waterways)ECHA: European Chemicals AgencyOSHA: Occupational Safety and Health Administration (USA)ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning theInternational Carriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)HMIS: Hazardous Materials Identification System (USA)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very Bioaccumulative

· Sources• Manufacturers' MSDSs/SDSs• OSHA (https://www.osha.gov/dts/chemicalsampling/toc/chmcas.html)• TOXNET (http://toxnet.nlm.nih.gov/)• ECHA (http://echa.europa.eu/)• EnviChem (www.echemportal.org)

· Notes:CAS Registry Number is a Registered Trademark of the American Chemical Society.CHEMTREC® is a registered service mark of the American Chemistry Council, Inc.

· * Data compared to the previous version altered. This version replaces all previous versions.· Disclaimer:The information contained herein is believed to be true and accurate. However, all statements,recommendations or suggestions are made without any guarantee, representation or warranty, expressor implied, on our part. Therefore, no warranty is made or to be implied that the information set out inthis document is accurate or complete, and we accordingly exclude all liability in connection with the useof this information or the products referred to herein. All such risks are assumed by the purchaser/user.The information contained herein is also subject to change without notice. For the avoidance of doubt,however, nothing in this document excludes or limits our liability for death or personal injury caused byour negligence or for fraudulent misrepresentation.

USA

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Dentin Bonding Agent - Etch

Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 1 of 6

according to Regulation (EC) No 1907/2006

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1001071 1.1. Product identifier

Product group: 1.2. Relevant identified uses of the substance or mixture and uses advised against 1.3. Details of the supplier of the safety data sheet

Henry Schein, Inc. Company name: 135 Duryea Road Street: Melville, NY 11747 City/State:

Telephone: 1-800-472-4346 Telefax e-mail: Internet:

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture Indications of danger: C - Corrosive R phrases: Causes burns.

GHS classification Hazard categories: Skin corrosion/irritation: Skin Corr. 1B Serious eye damage/eye irritation: Eye Dam. 1 Hazard Statements: Causes severe skin burns and eye damage.

2.2. Label elements Hazardous components which must be listed on the label

Phosphoric acid ... %; orthophosphoric acid Signal word: Danger Pictograms: GHS05

Causes severe skin burns and eye damage. Hazard statements

Wear protective gloves/protective clothing/eye protection/face protection. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Precautionary statements

SECTION 3: Composition/information on ingredients

3.2. Mixtures

PHOSPHORIC ACID Chemical characterization

Revision No: 1,01 Revision date: 12.09.2012 GB - EN

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 2 of 6

according to Regulation (EC) No 1907/2006

Hazardous components

GHS classification

Quantity Classification CAS No

REACH No Index No

EC No Chemical name

30 - 45 % Phosphoric acid ... %; orthophosphoric acid 231-633-2 C - Corrosive R34 7664-38-2 Skin Corr. 1B; H314 015-011-00-6

Full text of R and H phrases: see Section 16.

SECTION 4: First aid measures

4.1. Description of first aid measures

not applicable After inhalation

After contact with skin, wash immediately with: Water and soap. After contact with skin

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. After contact with eyes

Immediately get medical attention. After ingestion

SECTION 5: Firefighting measures

5.1. Extinguishing media

Material is not combustible. Additional information

SECTION 6: Accidental release measures

Wear suitable protective clothing. 6.1. Personal precautions, protective equipment and emergency procedures

Do not empty into drains or the aquatic environment. 6.2. Environmental precautions

Absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents). 6.3. Methods and material for containment and cleaning up

SECTION 7: Handling and storage

7.1. Precautions for safe handling

Keep container tightly closed. Wear suitable protective clothing and gloves. Avoid contact with eyes. Advice on safe handling

Ensure adequate ventilation of the storage area. Further information on handling

7.2. Conditions for safe storage, including any incompatibilities

Keep container tightly closed in a cool, well-ventilated place. Store only in original container.

Requirements for storage rooms and vessels

Do not store together with: Alkalis (alkalis). metal. Advice on storage compatibility

Revision No: 1,01 Revision date: 12.09.2012 GB - EN

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Dentin Bonding Agent - Etch

Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 3 of 6

according to Regulation (EC) No 1907/2006

SECTION 8: Exposure controls/personal protection

8.1. Control parameters

Exposure limits (EH40)

Category fibres/ml mg/m³ ppm Substance CAS No Origin TWA (8 h) - Orthophosphoric acid 7664-38-2 1 WEL

STEL (15 min) - 2 WEL

8.2. Exposure controls

When using do not eat or drink. Protective and hygiene measures

The following must be prevented: inhalation. Exceeding critical value: Filter respirator (full mask or mouth-piece) with filter: A

Respiratory protection

Wear suitable gloves.: NBR (Nitrile rubber). Butyl rubber. Hand protection

Tightly sealed safety glasses. Eye protection

blue Jelly Physical state:

Colour:

9.1. Information on basic physical and chemical properties

SECTION 9: Physical and chemical properties

Test method pH-Value: ca. 1

Changes in the physical state 100 °C Boiling point:

not applicable Flash point:

not applicable Lower explosion limits: Upper explosion limits:

not applicable Ignition temperature: Vapour pressure: (at 23 °C)

20 hPa

1,4 g/cm³ Density: Water solubility: easily soluble.

< 1 Vapour density:

SECTION 10: Stability and reactivity

Alkalis (alkalis). 10.5. Incompatible materials

Revision No: 1,01 Revision date: 12.09.2012 GB - EN

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Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 4 of 6

according to Regulation (EC) No 1907/2006

SECTION 11: Toxicological information

11.1. Information on toxicological effects

LD50: Rat. >810mg/kg Acute toxicity

Irritant effect on the eye: Causes burns. After skin contact: Causes burns.

Irritation and corrosivity

SECTION 12: Ecological information

12.1. Toxicity CAS No Chemical name

h Aquatic toxicity Method Dose Source Species Phosphoric acid ... %; orthophosphoric acid 7664-38-2 Acute fish toxicity 96 LC50 138 mg/l Gambusia affinis

Do not empty into drains or the aquatic environment. Leakage into the environment must be prevented. Further information

SECTION 13: Disposal considerations

13.1. Waste treatment methods Advice on disposal

Remove according to the regulations. Waste disposal number of waste from residues/unused products 180106 WASTES FROM HUMAN OR ANIMAL HEALTH CARE AND/OR RELATED RESEARCH (except kitchen

and restaurant wastes not arising from immediate health care); wastes from natal care, diagnosis, treatment or prevention of disease in humans; chemicals consisting of or containing dangerous substances Classified as hazardous waste.

SECTION 14: Transport information

Land transport (ADR/RID) 1805 14.1. UN number: PHOSPHORIC ACID SOLUTION 14.2. UN proper shipping name: 8 14.3. Transport hazard class(es): III 14.4. Packing group: 8 Hazard label:

Classification code: C1 Limited quantity: 5 L Transport category: 3

80 Hazard No: Tunnel restriction code: E

Revision No: 1,01 Revision date: 12.09.2012 GB - EN

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Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 5 of 6

according to Regulation (EC) No 1907/2006

Other applicable information (land transport)

Marine transport (IMDG) 1805 14.1. UN number: PHOSPHORSÄURE, LÖSUNG 14.2. UN proper shipping name: 8 14.3. Transport hazard class(es): III 14.4. Packing group: 8 Hazard label:

223 Special Provisions: Limited quantity: 5 L

F-A, S-B EmS:

Other applicable information (marine transport)

Air transport (ICAO) 1805 14.1. UN number: PHOSPHORSÄURE, LÖSUNG 14.2. UN proper shipping name: 8 14.3. Transport hazard class(es): III 14.4. Packing group: 8 Hazard label:

A3 Special Provisions: Limited quantity Passenger: 1 L

852 IATA-packing instructions - Passenger: 5 L IATA-max. quantity - Passenger: 856 IATA-packing instructions - Cargo: 60 L IATA-max. quantity - Cargo:

E1 : Y841

Other applicable information (air transport)

14.5. Environmental hazards no Dangerous for the environment:

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture National regulatory information

1 - slightly water contaminating Water contaminating class (D):

SECTION 16: Other information

Full text of R phrases referred to under Sections 2 and 3 Causes burns.

Revision No: 1,01 Revision date: 12.09.2012 GB - EN

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Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 6 of 6

according to Regulation (EC) No 1907/2006

Full text of H statements referred to under Sections 2 and 3 Causes severe skin burns and eye damage.

(The data for the hazardous ingredients were taken respectively from the last version of the sub-contractor's safety data sheet.)

Revision No: 1,01 Revision date: 12.09.2012 GB - EN

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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Dentin Bonding Agent - Liquid

Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 1 of 6

according to Regulation (EC) No 1907/2006

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1001071 1.1. Product identifier

Product group: 64-17-5 CAS No: 603-002-00-5 Index No: 200-578-6 EC No:

1.2. Relevant identified uses of the substance or mixture and uses advised against 1.3. Details of the supplier of the safety data sheet

Henry Schein, Inc. Company name: 135 Duryea Road Street: Melville, NY 11747 City/State:

Telephone: 1-800-472-4346 Telefax: e-mail: Internet:

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture Indications of danger: F - Highly flammable R phrases: Highly flammable. May cause sensitisation by skin contact.

GHS classification Hazard Statements: Highly flammable liquid and vapour.

2.2. Label elements Signal word: Danger Pictograms: GHS02

Highly flammable liquid and vapour. Hazard statements

Keep container tightly closed. Keep away from heat/sparks/open flames/hot surfaces. - No smoking. Keep out of reach of children.

Precautionary statements

SECTION 3: Composition/information on ingredients

3.2. Mixtures

Ethanol. Chemical characterization

Sum formula: C2H6O Molecular weight: 46,07

Revision No: 1,01 Revision date: 03.07.2014 GB - EN

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Dentin Bonding Agent - Liquid

Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 2 of 6

according to Regulation (EC) No 1907/2006

Hazardous components

GHS classification

Quantity Classification CAS No

REACH No Index No

EC No Chemical name

< 100 % ethanol, ethyl alcohol 200-578-6 F - Highly flammable R11 64-17-5 Flam. Liq. 2; H225 603-002-00-5

Full text of R and H phrases: see Section 16.

SECTION 4: First aid measures

4.1. Description of first aid measures

Move victim to fresh air. Put victim at rest and keep warm. After inhalation

After contact with skin, wash immediately with: Water and soap. Change contaminated clothing. Rub in high-fat content cream.

After contact with skin

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. After contact with eyes

If swallowed, immediately drink: Water. Consult physician. After ingestion

SECTION 5: Firefighting measures

5.1. Extinguishing media

Atomized water. alcohol resistant foam. Carbon dioxide (CO2). Extinguishing powder. Sand. Suitable extinguishing media

High power water jet. Extinguishing media which must not be used for safety reasons

5.2. Special hazards arising from the substance or mixture Concentrated vapors are heavier than air. Vapours may form explosive mixtures with air.

In case of fire: Wear self-contained breathing apparatus. 5.3. Advice for firefighters

SECTION 6: Accidental release measures

Keep away from sources of ignition - No smoking. The following must be prevented: inhalation. skin contact. Eye contact.

6.1. Personal precautions, protective equipment and emergency procedures

Do not empty into drains or the aquatic environment. 6.2. Environmental precautions

Absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents). 6.3. Methods and material for containment and cleaning up

SECTION 7: Handling and storage

7.1. Precautions for safe handling

Keep away from sources of ignition - No smoking. Provide adequate ventilation. Advice on safe handling

Revision No: 1,01 Revision date: 03.07.2014 GB - EN

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Dentin Bonding Agent - Liquid

Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 3 of 6

according to Regulation (EC) No 1907/2006

7.2. Conditions for safe storage, including any incompatibilities

Keep container tightly closed in a cool, well-ventilated place. Store only in original container.

Requirements for storage rooms and vessels

SECTION 8: Exposure controls/personal protection

8.1. Control parameters

Exposure limits (EH40)

Category fibres/ml mg/m³ ppm Substance CAS No Origin TWA (8 h) 1000 Ethanol 64-17-5 1920 WEL

STEL (15 min) - - WEL

8.2. Exposure controls

When using do not eat or drink. Protective and hygiene measures

The following must be prevented: inhalation. Exceeding critical value: Filter respirator (full mask or mouth-piece) with filter: A

Respiratory protection

Tested protective gloves are to be worn: Suitable material: NBR (Nitrile rubber). Hand protection

Tightly sealed safety glasses. Eye protection

colourless-transparent liquid Physical state:

Colour:

9.1. Information on basic physical and chemical properties

SECTION 9: Physical and chemical properties

characteristic Odour: Test method

pH-Value: neutral

Changes in the physical state ca. -115 °C Melting point:

ca. 80 °C Boiling point: 12 °C Flash point:

3.5 vol. % Lower explosion limits: 15 vol. % Upper explosion limits:

425 °C Ignition temperature: Vapour pressure: (at 20 °C)

59 hPa

Density (at 20 °C): ca. 0,8 g/cm³ Water solubility: complete miscible

Revision No: 1,01 Revision date: 03.07.2014 GB - EN

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Dentin Bonding Agent - Liquid

Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 4 of 6

according to Regulation (EC) No 1907/2006

Viscosity / dynamic: (at 20 °C)

1,3 mPa·s

SECTION 10: Stability and reactivity

heat. 10.4. Conditions to avoid

Oxidizing agents. peroxides. acid. Alkali metals. 10.5. Incompatible materials

SECTION 11: Toxicological information

11.1. Information on toxicological effects

Acute toxicity, oral LD50: (species: Rat.): > 6200 mg/kg; Acute toxicity, inhalant 95.6 mg / l /4 h Acute toxicity

Chemical name CAS No Species Dose Method Exposure routes Source

64-17-5 ethanol, ethyl alcohol Rat LD50 6200 mg/kg IUCLID oral

inhalative (4 h) vapour LC50 95,6 mg/l Rat RTECS

In case of prolonged or frequently repeated skin contact: irritant.; Following eye contact: irritant. Irritation and corrosivity

SECTION 12: Ecological information

Acute fish toxicity (Leuciscus idus): LC50: > 8140 mg / l / 48 h (Ethanol); Acute Daphnia toxicity (Daphnia magna): EC50: 9268 - 14221 mg / l / 48 h

12.1. Toxicity

CAS No Chemical name h Aquatic toxicity Method Dose Source Species

ethanol, ethyl alcohol 64-17-5 Acute crustacea toxicity 48 IUCLID EC50 9268 - 14221

mg/l Daphnia magna

Easily biodegradable (concerning to the criteria of the OECD) 12.2. Persistence and degradability

12.3. Bioaccumulative potential

Partition coefficient n-octanol/water Log Pow CAS No Chemical name

64-17-5 ethanol, ethyl alcohol -0,31

SECTION 13: Disposal considerations

13.1. Waste treatment methods Advice on disposal

Remove according to the regulations. Waste disposal number of waste from residues/unused products

Revision No: 1,01 Revision date: 03.07.2014 GB - EN

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Dentin Bonding Agent - Liquid

Safety Data Sheet

Product code: 1001071 Print date: 29.07.2014 Page 5 of 6

according to Regulation (EC) No 1907/2006

180106 WASTES FROM HUMAN OR ANIMAL HEALTH CARE AND/OR RELATED RESEARCH (except kitchen and restaurant wastes not arising from immediate health care); wastes from natal care, diagnosis, treatment or prevention of disease in humans; chemicals consisting of or containing dangerous substances Classified as hazardous waste.

SECTION 14: Transport information

Land transport (ADR/RID) 1170 14.1. UN number: ETHANOL (ETHYL ALCOHOL) 14.2. UN proper shipping name: 3 14.3. Transport hazard class(es): II 14.4. Packing group: 3 Hazard label:

Classification code: F1 Special Provisions: 144 601 Limited quantity: 1 L Transport category: 2

33 Hazard No: Tunnel restriction code: D/E

Other applicable information (land transport)

Marine transport (IMDG) 1170 14.1. UN number: ETHANOL (ETHYLALKOHOL) 14.2. UN proper shipping name: 3 14.3. Transport hazard class(es): II 14.4. Packing group: 3 Hazard label:

144 Special Provisions: Limited quantity: 3 L

F-E, S-D EmS:

Other applicable information (marine transport)

Air transport (ICAO) 1170 14.1. UN number: ETHANOL (ETHYLALKOHOL) 14.2. UN proper shipping name: 3 14.3. Transport hazard class(es): II 14.4. Packing group: 3 Hazard label:

Revision No: 1,01 Revision date: 03.07.2014 GB - EN

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Dentin Bonding Agent Liquid

Safety Data Sheet

Product code: 1001071

Print date: 29.07.2014 Page 6 of 6

according to Regulation (EC) No 1907/2006

A3 Special Provisions: Limited quantity Passenger: 1 L

353 IATA-packing instructions - Passenger: 5 L IATA-max. quantity - Passenger: 364 IATA-packing instructions - Cargo: 60 L IATA-max. quantity - Cargo:

E2 : Y341

Other applicable information (air transport)

14.5. Environmental hazards no Dangerous for the environment:

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture National regulatory information

SECTION 16: Other information

Full text of R phrases referred to under Sections 2 and 3 Highly flammable. May cause sensitisation by skin contact.

Full text of H statements referred to under Sections 2 and 3 Highly flammable liquid and vapour.

(The data for the hazardous ingredients were taken respectively from the last version of the sub-contractor's safety data sheet.)

Revision No: 1,01 Revision date: 03.07.2014 GB - EN

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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Dentin Bonding Agent - Resin

Safety Data Sheet

Product code:1001071 Print date: 29.07.2014 Page 1 of 4

according to Regulation (EC) No 1907/2006

SECTION 1: Identification of the substance/mixture and of the company/undertaking

.1. Product identifier 1001071

1.2. Relevant identified uses of the substance or mixture and uses advised against 1.3. Details of the supplier of the safety data sheet

Henry Schein, Inc. Company name: 135 Duryea Road Street: Melville, NY 11747 City/State:

Telephone: 1-800-472-4346 Telefax: e-mail: Internet:

SECTION 2: Hazards identification

2.1. Classification of the substance or mixture Indications of danger: Xi - Irritant R phrases: Irritating to eyes, respiratory system and skin. May cause sensitisation by skin contact.

GHS classification Hazard Statements: May cause respiratory irritation. Causes serious eye irritation. Causes skin irritation. May cause an allergic skin reaction.

2.2. Label elements Signal word: Warning Pictograms: GHS07

May cause respiratory irritation. Causes serious eye irritation. Causes skin irritation. May cause an allergic skin reaction.

Hazard statements

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. IF ON SKIN: Wash with plenty of soap and water. Wear protective gloves/protective clothing/eye protection/face protection.

Precautionary statements

SECTION 3: Composition/information on ingredients

3.2. Mixtures

chemical characterization (preparation): Acrylate.-resin. Chemical characterization

Revision No: 1,00 Revision date: 20.09.2012 GB - EN

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Dentin Bonding Agent - Resin

Safety Data Sheet

Product code: 1001071 P i d 29 07 2014

Page 2 of 4

according to Regulation (EC) No 1907/2006

SECTION 4: First aid measures

4.1. Description of first aid measures

Move victim to fresh air. Put victim at rest and keep warm. After inhalation

After contact with skin, wash immediately with: Water and soap. After contact with skin

In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. After contact with eyes

Immediately get medical attention. After ingestion

SECTION 5: Firefighting measures

5.1. Extinguishing media

Water fog. Extinguishing powder. Sand. Foam. Carbon dioxide (CO2). Suitable extinguishing media

High power water jet. Extinguishing media which must not be used for safety reasons

SECTION 6: Accidental release measures

Wear suitable protective clothing. Provide adequate ventilation. 6.1. Personal precautions, protective equipment and emergency procedures

Do not empty into drains or the aquatic environment. 6.2. Environmental precautions

Collect mechanically. 6.3. Methods and material for containment and cleaning up

SECTION 7: Handling and storage

7.1. Precautions for safe handling

Keep container tightly closed. Wear suitable protective clothing and gloves. Avoid contact with eyes. Advice on safe handling

7.2. Conditions for safe storage, including any incompatibilities

Keep container tightly closed in a cool, well-ventilated place. Store only in original container.

Requirements for storage rooms and vessels

SECTION 8: Exposure controls/personal protection

8.1. Control parameters 8.2. Exposure controls

Ensure adequate ventilation of the storage area. Occupational exposure controls

Revision No: 1,00 Revision date: 20.09.2012 GB - EN

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Dentin Bonding Agent - Resin

Safety Data Sheet

Product code 1001071

Print date: 29.07.2014 Page 3 of 4

according to Regulation (EC) No 1907/2006

When using do not eat or drink.

The following must be prevented: inhalation. Respiratory protection

Tested protective gloves are to be worn: Suitable material: NBR (Nitrile rubber). Hand protection

Tightly sealed safety glasses. Eye protection

yellow liquid Physical state:

Colour:

9.1. Information on basic physical and chemical properties

SECTION 9: Physical and chemical properties

like: ester Odour: Test method

pH-Value (at 20 °C): 3.5

Changes in the physical state > 200 °C point of decomposition: > 150 °C Flash point: 1.3 g/cm³ Density:

> 1 Vapour density:

SECTION 10: Stability and reactivity

Light. heat. Decompostion takes place from temperatures above: 200 °C Decomposition under formation of: Acrylate.

10.4. Conditions to avoid

Keep away from strong acids, leachates, heavy metal salts and reducing materials. 10.5. Incompatible materials

Can be released in case of fire: Gas / vapours, irritant. (Acrylate., pungent) 10.6. Hazardous decomposition products

Substances sensitive to light. Further information

SECTION 11: Toxicological information

11.1. Information on toxicological effects

LD50: Rat. 2000 mg/kg Acute toxicity

Frequently or prolonged contact with skin may cause dermal irritation. Irritant effect on the eye:

Irritation and corrosivity

May cause sensitization by skin contact. Sensitising effects

Contains Methacrylic esters.: May produce an allergic reaction. Additional information on tests

Revision No: 1,00 Revision date: 20.09.2012 GB - EN

Protective and hygiene measures

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Dentin Bonding Agent - Resin

Safety Data Sheet

Product code: 1001071

Print date: 29.07.2014 Page 4 of 4

according to Regulation (EC) No 1907/2006

SECTION 12: Ecological information

Preparation not tested. 12.2. Persistence and degradability

Do not empty into drains or the aquatic environment. Leakage into the environment must be prevented. Further information

SECTION 13: Disposal considerations

13.1. Waste treatment methods Advice on disposal

Can be burnt together with household waste in compliance with official regulations in contact with approved waste disposal companies and with authorities in charge. Paste: Carry out a burning of harzardous waste according to official regulations.

Waste disposal number of waste from residues/unused products 180106 WASTES FROM HUMAN OR ANIMAL HEALTH CARE AND/OR RELATED RESEARCH (except kitchen

and restaurant wastes not arising from immediate health care); wastes from natal care, diagnosis, treatment or prevention of disease in humans; chemicals consisting of or containing dangerous substances Classified as hazardous waste.

SECTION 14: Transport information

Not a hazardous material with respect to these transportation regulations. Other applicable information

SECTION 15: Regulatory information

15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture National regulatory information

2 - water contaminating Water contaminating class (D):

SECTION 16: Other information

Full text of R phrases referred to under Sections 2 and 3 Irritating to eyes, respiratory system and skin. May cause sensitisation by skin contact.

Full text of H statements referred to under Sections 2 and 3 Causes skin irritation. May cause an allergic skin reaction. Causes serious eye irritation. May cause respiratory irritation.

- Further Information

(The data for the hazardous ingredients were taken respectively from the last version of the sub-contractor's safety data sheet.)

Revision No: 1,00 Revision date: 20.09.2012 GB - EN

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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Safety Data Sheet

Section 1: Identification

Product Name: Criterion LP Powdered Latex Examination Gloves CAS Number: Not established Product Use: Examination Glove Distributed by: Henry Schein, Inc. Address: 135 Duryea Road, Melville, NY 11747 Telephone: 1-800-472-4346 Emergency: Chemtree 1-800-424-9300

Section 2: Hazard(s) Identification

Not Established

Section 3: Composition/Information on Ingredients

Natural Rubber Latex (90%) Sulfur Zinc Oxide Organic Accelerators Dithiocarbamates U.S.P. Absorbable Dusting Powder Color: White Odor: N/A

Section 4: First-Aid Measures

Isolated cases of allergic reactions to latex rubber have been reported. This product contains natural rubber latex, which may cause allergic reactions.

Dusted with absorbable corn starch powder (USP). Powder may be irritating to the respiratory tract or eyes. Users should consider the circumstances of use in deciding whether to remove any residual powder on gloves after donning. Powder can be removed by wiping the gloves thoroughly with a sterile wet sponge, sterile wet towel or other effective method.

Section 5: Fire-Fighting Measures

Flash Point N/A Extinguishing Media Foam, Carbon Dioxide, Water Conditions to Avoid None Incompatible Materials None

Section 6: Accidental Release Measures

Not necessary

Section 7: Handling and Storage

Store in cool dry conditions. Avoid excessive heat. Open box should be kept from exposure to direct

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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sun or fluorescent lighting.

Section 8: Exposure Controls/Personal Protection

Not necessary

Section 9: Physical and Chemical Properties

N/A

Section 10: Stability and Reactivity

Stable

Section 11: Toxicological Information

N/A

Section 12: Ecological Information* (non-mandatory)

N/A

Section 13: Disposal Considerations* (non-mandatory)

Material may be recycled or disposed of in accordance with local regulations.

Section 14: Transport Information* (non-mandatory)

N/A

Section 15: Regulatory Information* (non-mandatory)

N/A

Section 16: Other Information

Rev. 09-14

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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GENERAL BUSINESS: 631-843-5500

http://www.henryschein.com

Henry Schein, Inc. 135 Duryea Road Melville, NY 11747

Safety Data Sheet

Section 1: Identification

Product Name TAISOX 3470 Synonyms Polyethylene Homopolymer CAS Number 9002-88-4Product Use According to manufacturer's directions. Compounding. Manufacturer/Supplier Formosa Plastics Corporation Address Formosa Industrial Park No.1, Mailiao, Yunlin county, Taiwan

General Information +886-5- 6811180 Transportation Emergency Number +886-5- 6811180

Section 2: Hazard(s) Identification

Referring to EEC directive 88/379, the material is classified NOT DANGEROUSMain personal hazards

Fire Combustion products: Carbon dioxide, water. In case of incomplete combustion: carbon monoxide, hydrocarbons, aldehydes, ketones and acetic acid may be developed. Slipping in case of spillage/leakage scoop to container to avoid danger of skidding Hazard of contact with molten polymer If molten polymer gets on skin, cool rapidly with cool water. Burns have to be treated clinically. EYES Wash abundantly with water.

Powders have specific fire risks Environment: Lack of biodegradability

Section 3: Composition/Information on Ingredients

Technical name Linear Low Density Polyethylene,LLDPE

Chemical name Polyethylene Homopolymer

Ingredient percent(%) LLDPE 98.85% Other 1.15

Chemical Abstracts Number (CAS No.) 9002-88-4

Symbol of the basic polymer against standard ISO 1043-1 PE-LLD

Dangerous components NONE

Section 4: First-Aid Measures

Skin If molten polymer gets on skin, cool rapidly with cool water. Burns have to be treated clinically.

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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Eyes Wash abundantly with water

Section 5: Fire-Fighting Measures

Suitable Extinguishing Media Water, Water fog, CO2, Foam or dry extinguishers

Exting. Media to be avoided NONE

Combustion products Carbon dioxide, water. In case of incomplete combustion: carbon, monoxide, hydrocarbons, aldehydes, ketones and acetic acid may be developed.

Section 6: Accidental Release Measures

None

Section 7: Handling and Storage

During the processing of the material, avoid inhalation of fumes, or powders, by providing good ventilation of the workroom and, if necessary, they have to be trapped by intake in an effective manner. If these measures are taken, traces of aldehydes or ketones which may arise during the process, will remain under the TLV/TWA value. Avoid dispersion of dust in air to reduce potential for ignition or explosions. Storage Out of direct sun, in well ventilated, cool and dry places Fire precautions Equipment must be earthed, to avoid static electric charges. Any contact with flame or hot surface must be avoided.

Section 8: Exposure Controls/Personal Protection

Use gloves, goggles or eyeshade and normal working equipment. In case of powder, avoid inhalation.

Section 9: Physical and Chemical Properties

Appearance Solid Form Pellet

Color : Translucent Odor: none

Specific Gravity 0.915-0.935 g/cm3 Boiling Point N/A

Auto-ignition Temperature ca.340 Flash Point 570 300

Decomposition Temperature > 400 Test Method Close Cup

Vapor Pressure (Below) mmHg@20 Solubility in Water Negligible

Section 10: Stability and Reactivity

Stable and chemically inert at room temperature. Protracted exposure to temperature over 250 may cause resin degradation.

Section 11: Toxicological Information

Exposures limits for the monomer have not been fixed. Avoid exposure to fume, eventually developed during the process, by intake and/or efficient ventilation of the working rooms.

TWA(ACGIH) for dust = 5 mg/m3

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Section 12: Ecological Information* (non-mandatory)

The product is not biodegradable. It can be recycled using suitable technologies. It does not contain, as additives, compounds of lead, mercury, cadmium and chromium. It does not contain asbestos, CFC, HCFC, haloes. It is not a water endangering material. It is very slowly degraded by solar UV irradiation.

Section 13: Disposal Considerations* (non-mandatory)

Disposal must be done in accordance with existing regulations. Landfilling and incineration can be considered in most cases suitable. Recycling is possible by melting and pelletizing.

Section 14: Transport Information* (non-mandatory)

According to RIR-ADR, IMO, IATA, IMDG, FS A11 the product is not dangerous. On loading and unloading, equipment must be earthed to avoid static electric charges.

Section 15: Regulatory Information* (non-mandatory)

None

Section 16: Other Information

The information provided is given in good faith and is based on our actual knowledge.

This is not a technical sheet for use of the product.

This sheet does not exempt the user from knowing and applying all the relevant regulations and from taking all the relevant safety precautions.

Revision: 2014.03.06

*Note: Since other Agencies regulate this information, OSHA will not be enforcing Sections 12 through 15(29 CFR 1910.1200(g)(2)).

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HENRY SCHEIN PRIVATE LABEL PRODUCTS by this material

HS Part # Description

============= ============================================

DENTURE BOXES SERIES

900-4013 DENTURE BOXES BEIGE (12 PCS/BAG)

900-4015 DENTURE BOXES MAUVE (12 PCS/BAG)

900-4016 DENTURE BOXES BLUE (12 PCS/BAG)

102-7476 DENTURE BOXES WHITE (12 PCS/BAG)

102-7377 DENTURE BOXES ASSORTED (12 PCS/BAG)

~Verified on 2014-10 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-10. ~

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~Verified on 2014-12 by H enry Schein to be the m ost current version of the SDS. To be verified again on 2017-12. ~

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~Verified on 2014-12 by H enry Schein to be the m ost current version of the SDS. To be verified again on 2017-12. ~

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Safety Data Sheet

Section 1: Identification

Section 1, Identification includes product identifier; manufacturer or distributor name, address, phone number; emergency phone number; recommended use; restrictions on use.

Product Identifier : Criterion Nitrile EC Powder Free Nitrile Examination Gloves Distributed By : Henry Schein, Inc. Address : 135 Duryea Road City, State, Zip : Melvil le, NY 11747 Phone Number : 1-800-472-4346 Emergency Phone Number : Chemtrec 1-800-424-9300 Recommended Use : Instruction for use is not included because the gloves can be used

safely. Restriction for Use : These gloves are not made from natural rubber latex. They may

contain residual chemicals used in their manufacture that can cause allergic skin reactions in some people. If skin reaction occurs, discontinue use.

Section 2: Hazard(s) Identification

Section 2, Hazard(s) identification includes all hazards regarding the chemical; required label elements.

No Hazardous chemical is used in manufacturing of gloves.

Section 3: Composition/Information on Ingredients

Section 3, Composition/information on ingredients includes information on chemical ingredients; trade secret claims.

Carboxylated Butadiene Acrylonitrile Polymer Latex (100phr), Sodium Dodecylbenzenesulfonate (0.4-0.8phr), Sulphur (0.7-1.2phr), Zinc Oxide (0.8-1.3phr), Zinc-Di-n-butyldithiocarbamate (0.2-0.5phr), Zinc Mercaptobenzothiazole (0.2-0.5phr) Titanium Dioxide (1.5-2.0phr), Paraffin Wax Emulsion (2.0-2.5phr), Pigment PL1508 (0.01-0.05phr), Pigment Corn Flower (0.05-0.15)

Section 4: First-Aid Measures

Section 4, First-aid measures includes important symptoms/ effects, acute, delayed; required treatment.

If reaction in the form of skin irritation is notices, remove gloves immediately and wash effected part with saline water. If there is no relief, seek medical reactions.

~Verified on 2014-11 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-11. ~

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Section 5: Fire-Fighting Measures

Section 5, Fire-fighting measures lists suitable extinguishing techniques, equipment; chemical hazards from fire.

Flashpoint N/A

Autoignition Temperature N/A

Flammable Limits in Air N/A

Extinguishing Media Chemical foam and dry chemical may be used Fire-Fighting Procedures Use standard procedure for combustion material fires, including approved self -contained breathing apparatus Fire and Explosion Hazards No fire or explosion hazards are associated with these products. They will melt at elevated temperature

Section 6: Accidental Release Measures

Section 6, Accidental release measures lists emergency procedures; protective equipment; proper methods of containment and cleanup.

Biocompatibility The chemical formulation of the gloves and surface lubrication materials does not contain any substances normally known to be harmful to the user or to any person with whom the gloves come into contact.

Medical Conditions Generally Aggravated by Exposure Nitrile Powder Free Gloves are not expected to cause any adverse health effects.

Section 7: Handling and Storage

Section 7, Handling and storage lists precautions for safe handling and storage, including incompatibilities.

Precaution to be Taken in Handling and Storage Store in a dry, cool and ventilated area. Do not store above 104°F (40°C). Shield open box from direct sunlight, fluorescent lighting and x-rays. Improper storage will decrease usable life.

Section 8: Exposure Controls/Personal Protection

Section 8, Exposure controls/personal protection lists OSHA's Permissible Exposure Limits (PELs); Threshold Limit Values (TLVs); appropriate engineering controls; personal protective equipment (PPE).

Eye Protection Not necessary under conditions of intended use.

Skin Protection Not necessary under conditions of intended use.

Respiratory Protection Not necessary under conditions of intended use.

Ventilation Not necessary under conditions of intended use.

Steps to be Taken in Case Mater ial is Leaked or Spilled These products are solid articles and are not subject to leaks or spills.

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Section 9: Physical and Chemical Properties

Section 9, Physical and chemical proper ties lists the chemical 's characteristics.

Appearance/Odor Ambidextrous, Beaded Cuff, Finger Textured, Chlorinated, Powder Free, Aqua Blue

Size Extra-Small Small Medium Large Extra-Large Length (mm) 290 ± 10 Width (mm) 76 ± 4 86 ± 4 98 ± 4 107± 4 115 ± 4 Thickness (mm) Single Wall (Same for All) Finger (mm) Palm (mm) Cuff (mm)

0.16 ± 0.02 0.12 ± 0.02 0.09 ± 0.02

Tensile Proper ties Unaged Aged Tensile Strength (MPa) Minimum 18.0 Minimum16.0 Ultimate Elongation (%) Minimum 500 Minimum 400

Section 10: Stability and Reactivity

Section 10, Stability and reactivity lists chemical stability and possibility of hazardous reactions.

Boiling Point N/A

Vapour Pressure (mm Hg) N/A

Vapor Density (air=1) N/A

Specific Gravity (water=1) N/A

Solubility in Water Insoluble

% Volatile by Volume N/A

Evaporation Rate N/A

Viscosity N/A

Section 11: Toxicological Information

Section 11, Toxicological information includes routes of exposure; related symptoms, acute and chronic effects; numerical measures of toxicity.

Stability Stable

Condition to Avoid Does Not Apply

Incompatibility (Materials to Avoid) High polar solvent like methyl ethyl ketone, acetone

Hazardous Decomposition Products In a fire, these products may produce a black smoke. Carbon Dioxide, Carbon Monoxide, Oxides or Nitrogen, aromatic/ aliphatic hydrocarbons

Hazardous Polymerization Will not occur

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Section 12: Ecological Information* (non-mandatory)

Not mandatory but keep section in document and leave empty/blank

Section 13: Disposal Considerations* (non-mandatory)

Not mandatory but keep section in document and leave empty/blank

Section 14: Transport Information* (non-mandatory)

Not mandatory but keep section in document and leave empty/blank

Section 15: Regulatory Information* (non-mandatory)

Not mandatory but keep section in document and leave empty/blank

Section 16: Other Information

Section 16, Other information, includes the date of preparation or last revision.

Date of Preparation : 5th November 2014

Revision : 01

*Note: Since other Agencies regulate this information, OSHA will not be enforcing Sections 12 through 15(29 CFR 1910.1200(g)(2)).

~Verified on 2014-11 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-11. ~

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MATERIAL SAFETY DATA SHEETMSDS_BeautifilⅡ.xls

1.Identificat ion of the substance or mixture and of the supplier 1.1 Product Name:

BEAUTIFIL Ⅱ 1.2 Company / Undertaking identification

Manufacturer's Name: SSHOFU INC. Address: 11 Kamitakamatsu- cho, Fukunine, Higashiyama- ku, Kyoto 605- 0983 ,JAPAN

Phone: +81- 75- 561- 1112Fax: +81- 75- 561- 2273Section in Charge: Quality Assurance Section Date Prepared: 2012.5.18

1.3 Emergency Telephone Number+81- 75- 561- 1112

2.Hazardous identificat ionGHS CLASSIFICATION PHYSICAL HAZARDS FLAMMABLE SOLIDS Not Classified

PYROPHORIC SOLIDS Not ClassifiedSELF-HEATING SUBSTANCES AND MIXTURES Not ClassifiedSUBSTANCES AND MIXTURES WHICH,IN CONTACTNot Classified WITH WATER,EMIT FLAMMABLE GASAS

HEALTH HAZARDS ACUTE TOXICITY-ORAL Not ClassifiedACUTE TOXICITY-DERMAL Not ClassifiedACUTE TOXICITY- INHALATION(VAPOURS) Not ClassifiedACUTE TOXICITY- INHALATION(DUST,MIST) Not ClassifiedSKIN CORROSION/ IRRITATION Not ClassifiedEYE DAMAGE/ IRRITATION Not ClassifiedSENSITIZATION-SKIN Not ClassifiedTOXIC TO REPRODUCTION Category 1ASPECIFIC TARGET ORGAN SYSTEMIC Not ClassifiedTOXICITY (SINGLE EXPOSURE)SPECIFIC TARGET ORGAN SYSTEMIC Not ClassifiedTOXICITY (REPEATED EXPOSURE)

ENVIRONMENTAL HAZARD HAZARDOUS TO THE AQUATIC Not ClassifiedENVIRONMENT-ACUTE HAZARDHAZARDOUS TO THE AQUATIC Not ClassifiedENVIRONMENT-CHRONIC HAZARD

The thing without mention is out of a classification object. Or cannot classify it.

LABEL ELEMENTS SYMBOL

SIGNAL WORD Danger

HAZARD STATEMENTS May damage fertility or the unborn child

1/ 4issue 3

~Verified on 2014-04 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-04. ~

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MATERIAL SAFETY DATA SHEETMSDS_BeautifilⅡ.xls

PRECAUTIONARY STATEMENTS[Prevention]Obtain special instruction before use.Do not handle until all safety precautions have been read and understood.Use personal protective equipment as required.[Response]Get medical advice/ attention if you feel unwell.[Storage]Store in a cool and dark area.(Keep refrigerated when not in use)[Disposal]Dispose of contents and container in accordance with regulation.

3.Composit ion/ information on ingredientsComposition %Bis-GMA [Cas No.1565- 94- 2] ≒ 7.5Triethylenglycol dimethacrylate [Cas No.109- 16- 0] < 5Aluminofluoro- borosilicate glass [Cas No.65997- 18- 4] ≒ 70Al2O3 [Cas No.1344- 28- 1]

DL-Camphorquinone [10373- 78- 1]Others Hazardous ingredients are not include.

4.First- aid measures 4.1 Eye contact : Rinse cautiously with water for several minutes. Remove contact lenses, if present

and easy to do. If eye irritation persists, get medical advice/ attention. 4.2 Skin contact : Wash with plenty of soap and water. If on skin, skin irritation, get medical

advice/ attention. 4.3 Ingestion : Rinse mouth. If you feel un-well, get medical advice/ attention. 4.4 Inhalation : Remove victim to flesh air and keep at rest in a position comfortable for breathing.

If symptom concerning breath gose out, call a POISON CENTER to doctor.

5.Fire- fight ing measures 5.1 Suitable Extinguishing Media: CO2, Dry chemical, Foam 5.2 Extinguishing Media Should not be used : N/ A 5.3 Special Exposure Hazards Arising: In case of fire, do not breath fumes and gases.

(Irritation gases and fumes may emit.) 5.4 Special Protective Equipment: Wear fire protective cloth and self- contained

breathing apparatus if necessary.

6.Accidental release measures 6.1 Personal Precautions: N/ A 6.2 Environmental Precautions: Dispose according to local, state and federal regulations. 6.3 Methods for Cleaning Up: Wipe up and discard in a suitable container.

7.Handling and storage 7.1 Handling: Avoid inhalation of grindings and prolonged skin contact with uncured resin.

2/ 4issue 3

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MATERIAL SAFETY DATA SHEETMSDS_BeautifilⅡ.xls

7.2 Storage: Store in a cool and dark area.(Keep refrigerated when not in use)

8.Exposure controls/ personal protect ion 8.1 Respiratory Protection: Not required.(Use dust mask while grinding or finishing.) 8.2 Hand Protection: Latex or rubber gloves 8.3 Eye Protection: Safety goggles (May be required) 8.4 Skin Protection: Not required.

9.Physical and chemical propert ies 9.1 Appearance/ Odour/ pH Colored putty- like paste with sweet odor 9.2 Boiling Point/ Boiling Range: N/ D 9.3 Melting Point/ Melting Range: N/ D 9.4 Flash point: N/ D 9.5 Auto flammability: N/ D 9.6 Explosive Properties: N/ D 9.7 Oxidizing Properties: N/ D 9.8 Vapour Pressure: N/ D 9.9 Relative Density: 2.25 (water=1) 9.10 Solubility: water solubility Insoluble

10.Stability and reactivity 10.1 Stability: Stable under the normal condition. 10.2 Reactivity: Polymerization will occur with heat, light. 10.3 Condition to avoid: Visible light and high- temperature.

Keep away from source of ignition.(- electric discharge and smoking etc.)

10.4 Materials to avoid: Strong oxidizing materials

11.Toxicological informationNo information

12.Ecological informationNo information

13.Disposal considerat ionsDispose of contents/ container to in accordance with local/ regional/ national/ international regulations (to be specified).

14.Transport informationAirline restriction information ; It doesn't correspond.UN No. ; It doesn't correspond.Sea restriction information ; It doesn't correspond.UN No. ; It doesn't correspond.

15.Regulatory information

3/ 4issue 3

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MATERIAL SAFETY DATA SHEETMSDS_BeautifilⅡ.xls

Follow all regulations in your country.

16.Other informationThis product is intended for use by dental professionals. (instrument/ material)

4/ 4issue 3

~Verified on 2014-04 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-04. ~

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Page 1/8Safety Data Sheet

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40.1.1

1 Identification· Product identifier· Trade name: Miracle Mix (Powder)· Relevant identified uses of the substance or mixture and uses advised againstDental materialThe product is intended for professional use.To avoid risks for humans and environment obtain instructions.

· Application of the substance / the mixture Dental filling material· Details of the supplier of the safety data sheet· Manufacturer/Supplier:GC America Inc.3737 W. 127th StreetAlsip, IL 60803USA

[email protected]· Information department: Regulatory Affairs· Emergency telephone number:During normal opening times (Mon.-Fri. 8:00 AM-5:00 PM CST): +1 (708) 597-0900Transportation (CHEMTREC®) Emergency Telephone No. +1 (800) 424-9300

2 Hazard(s) identification· Classification of the substance or mixtureThe product is not classified according to the Globally Harmonized System (GHS).

· Additional information:The information provided is in regards to the toxicity and hazard rating(s) of the individual component(s)in the formulation. The associated risk(s) depends on the route(s) of exposure. The hazard ratingsystem is based entirely on the existence of the risk(s) and does not take into account the likelihood ofreduced risk(s) through proper usage and handling.

· Label elements· GHS label elements Void· Hazard pictograms Void· Signal word Void· Hazard statements Void· Classification system:· NFPA ratings (scale 0 - 4)

00

0Health = 0Fire = 0Reactivity = 0

· HMIS-ratings (scale 0 - 4) HEALTH

FIRE

REACTIVITY

0

0

0

Health = 0Fire = 0Reactivity = 0

(Contd. on page 2) USA

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Page 2/8Safety Data Sheet

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Trade name: Miracle Mix (Powder)

(Contd. of page 1)

40.1.1

· Other hazards· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.

3 Composition/information on ingredients· Chemical characterization: Mixtures· Description: Mixture of the substances listed below with nonhazardous additions.· Dangerous components: Void· Additional information:If a substance is marked with **, then substance is a trade secret. This is allowed under OSHA’sHazard Communication Standard (HCS) as a trade secret and under GHS as Confidential BusinessInformation (CBI).

4 First-aid measures· Description of first aid measures· General information:No special measures required.If symptoms persist consult doctor.

· After inhalation:Supply fresh air; consult doctor in case of complaints.In case of unconsciousness place patient stably in side position for transportation.

· After skin contact:Rinse with warm water.If symptoms persist consult doctor.

· After eye contact:Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor.

· After swallowing:Rinse out mouth and then drink plenty of water.If symptoms persist consult doctor.

· Information for doctor:· Most important symptoms and effects, both acute and delayedNo further relevant information available.

· Indication of any immediate medical attention and special treatment neededNo further relevant information available.

5 Fire-fighting measures· Extinguishing media· Suitable extinguishing agents:CO2, extinguishing powder or water spray. Fight larger fires with water spray or alcohol resistant foam.Use fire fighting measures that suit the environment.

· For safety reasons unsuitable extinguishing agents: Water with full jet· Special hazards arising from the substance or mixtureFormation of toxic gases is possible during heating or in case of fire.

· Advice for firefighters· Protective equipment: Wear self-contained respiratory protective device.

(Contd. on page 3) USA

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Trade name: Miracle Mix (Powder)

(Contd. of page 2)

40.1.1

· Additional informationDispose of fire debris and contaminated fire fighting water in accordance with official regulations.

6 Accidental release measures· Personal precautions, protective equipment and emergency proceduresRemove persons from danger area.

· Environmental precautions:Do not allow product to reach sewage system or any water course.Inform respective authorities in case of seepage into water course or sewage system.Do not allow to penetrate the ground/soil.In case of seepage into the ground inform responsible authorities.

· Methods and material for containment and cleaning up:Pick up mechanically.Dispose of the collected material according to regulations.

· Reference to other sectionsSee Section 7 for information on safe handling.See Section 8 for information on personal protection equipment.See Section 13 for disposal information.

7 Handling and storage· Handling:· Precautions for safe handlingObserve instructions for use.Prevent formation of dust.Any deposit of dust which cannot be avoided must be regularly removed.

· Information about protection against explosions and fires:Dust can combine with air to form an explosive mixture.

· Storage:· Requirements to be met by storerooms and receptacles:Store only in unopened original receptacles.

· Information about storage in one common storage facility: Store away from foodstuffs.· Further information about storage conditions: Observe instructions for use / storage.· Specific end use(s) No further relevant information available.

8 Exposure controls/personal protection· Additional information about design of technical systems: No further data; see item 7.· Control parameters· Components with limit values that require monitoring at the workplace:The product does not contain any relevant quantities of materials with critical values that have to bemonitored at the workplace.

· Additional information: The lists that were valid during the creation were used as basis.· Exposure controls· Personal protective equipment:· General protective and hygienic measures:The usual precautionary measures for handling chemicals should be followed.Do not inhale dust / smoke / mist.

(Contd. on page 4) USA

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Trade name: Miracle Mix (Powder)

(Contd. of page 3)

40.1.1

Wash hands before breaks and at the end of work.· Breathing equipment: Suitable respiratory protective device recommended.· Protection of hands: Protective gloves· Material of glovesThe selection of the suitable gloves does not only depend on the material, but also on further marks ofquality and varies from manufacturer to manufacturer. As the product is a preparation of severalsubstances, the resistance of the glove material can not be calculated in advance and has therefore tobe checked prior to the application.

· Penetration time of glove materialThe exact break through time has to be found out by the manufacturer of the protective gloves and hasto be observed.

· Eye protection: Safety glasses

9 Physical and chemical properties· Information on basic physical and chemical properties· General Information· Appearance:

Form: PowderColor: Light yellow

· Odor: Odorless· Odor threshold: Not determined.· pH-value: Not applicable.· Change in condition

Melting point/Melting range: Undetermined.Boiling point/Boiling range: Undetermined.

· Flash point: Not applicable.· Flammability (solid, gaseous): Not determined.· Ignition temperature: Undetermined.· Decomposition temperature: Not determined.· Auto igniting: Product is not selfigniting.· Danger of explosion: Product does not present an explosion hazard.· Explosion limits:

Lower: Not determined.Upper: Not determined.

· Vapor pressure: Not applicable.· Density: Not determined.· Relative density Not determined.· Vapour density Not applicable.· Evaporation rate Not applicable.· Solubility in / Miscibility with

Water: Insoluble.· Partition coefficient (n-octanol/water): Not determined.

(Contd. on page 5) USA

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Trade name: Miracle Mix (Powder)

(Contd. of page 4)

40.1.1

· Viscosity:Dynamic: Not applicable.Kinematic: Not applicable.

· Solvent content:Organic solvents: 0.0 %

Solids content: 100.0 %· Other information No further relevant information available.

10 Stability and reactivity· Reactivity No further relevant information available.· Chemical stability Stable at ambient temperature.· Thermal decomposition / conditions to be avoided:No decomposition if used according to specifications.

· Possibility of hazardous reactions No dangerous reactions known.· Conditions to avoid No further relevant information available.· Incompatible materials: No further relevant information available.· Hazardous decomposition products: No dangerous decomposition products known.

11 Toxicological information· Information on toxicological effects· Acute toxicity:· LD/LC50 values that are relevant for classification: No further relevant information available.· Primary irritant effect:· on the skin: No irritant effect.· on the eye: No irritating effect.· Sensitization: No sensitizing effects known.· Additional toxicological information:The product is not subject to classification according to internally approved calculation methods forpreparations:

· Carcinogenic categories· IARC (International Agency for Research on Cancer)antimony nickel titanium oxide yellow 3 iron(III) oxide 3

· NTP (National Toxicology Program)None of the ingredients is listed.

· OSHA-Ca (Occupational Safety & Health Administration)None of the ingredients is listed.

· Carcinogenic categories' legend:(Contd. on page 6)

USA

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Trade name: Miracle Mix (Powder)

(Contd. of page 5)

40.1.1

IARC Group 1: The agent is carcinogenic to humans.IARC Group 2A: The agent is probably carcinogenic to humans.IARC Group 2B: The agent is possibly carcinogenic to humans.IARC Group 3: The agent is not classifiable as to its carcinogenicity to humans.IARC Group 4: The agent is probably not carcinogenic to humans.NTP K: Known to be human carcinogen.NTP R: Reasonably anticipated to be human carcinogen.

12 Ecological information· Toxicity· Aquatic toxicity: No further relevant information available.· Persistence and degradability No further relevant information available.· Behavior in environmental systems:· Bioaccumulative potential No further relevant information available.· Mobility in soil No further relevant information available.· Additional ecological information:· General notes:Water hazard class 3 (Self-assessment): extremely hazardous for waterDo not allow product to reach ground water, water course or sewage system, even in small quantities.Danger to drinking water if even extremely small quantities leak into the ground.

· Results of PBT and vPvB assessment· PBT: Not applicable.· vPvB: Not applicable.· Other adverse effects No further relevant information available.

13 Disposal considerations· Waste treatment methods· Recommendation: Smaller quantities can be disposed of with household waste.· Uncleaned packagings:· Recommendation: Disposal must be made according to official regulations.

14 Transport information· UN-Number· DOT, ADR, ADN, IMDG, IATA Void· UN proper shipping name· DOT, ADR, ADN, IMDG, IATA Void· Transport hazard class(es)· DOT, ADR, ADN, IMDG, IATA· Class Void· Packing group· DOT, ADR, IMDG, IATA Void

(Contd. on page 7) USA

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Trade name: Miracle Mix (Powder)

(Contd. of page 6)

40.1.1

· Environmental hazards:· Marine pollutant: No· Special precautions for user Not applicable.· Transport in bulk according to Annex II ofMARPOL73/78 and the IBC Code Not applicable.

· UN "Model Regulation": -

15 Regulatory information· Safety, health and environmental regulations/legislation specific for the substance or mixture· SARA (Superfund Amendments and Reauthorization Act)· Section 355 (extremely hazardous substances):None of the ingredient is listed.

· Section 313 (Specific toxic chemical listings):None of the ingredients is listed.

· TSCA (Toxic Substances Control Act):All ingredients are listed.

· Carcinogenic categories· EPA (Environmental Protection Agency)None of the ingredients is listed.

· TLV (Threshold Limit Value established by ACGIH)antimony nickel titanium oxide yellow A4iron(III) oxide A4

· NIOSH-Ca (National Institute for Occupational Safety and Health)None of the ingredients is listed.

· GHS label elements Void· Hazard pictograms Void· Signal word Void· Hazard statements Void· Chemical safety assessment: A Chemical Safety Assessment has not been carried out.

16 Other information· Department issuing MSDS: Regulatory Affairs· Contact:Regulatory AffairsTelephone No. +1 (708) [email protected]

· Date of preparation / last revision 02/24/2015 / -· Abbreviations and acronyms:

GHS: Globally Harmonized System of Classification and Labelling of ChemicalsHCS: Hazard Communication Standard (USA)MSDS: Material Safety Data SheetSDS: Safety Data Sheet

(Contd. on page 8) USA

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Trade name: Miracle Mix (Powder)

(Contd. of page 7)

40.1.1

ADN: Accord européen relatif au transport international des marchandises dangereuses par voies de navigation intérieures(European Agreement Concerning the International Carriage of Dangerous Goods by Inland Waterways)ECHA: European Chemicals AgencyOSHA: Occupational Safety and Health Administration (USA)ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning theInternational Carriage of Dangerous Goods by Road)IMDG: International Maritime Code for Dangerous GoodsDOT: US Department of TransportationIATA: International Air Transport AssociationACGIH: American Conference of Governmental Industrial HygienistsCAS: Chemical Abstracts Service (division of the American Chemical Society)NFPA: National Fire Protection Association (USA)HMIS: Hazardous Materials Identification System (USA)LC50: Lethal concentration, 50 percentLD50: Lethal dose, 50 percentPBT: Persistent, Bioaccumulative and ToxicvPvB: very Persistent and very Bioaccumulative

· Sources• Manufacturers' MSDSs/SDSs• OSHA (https://www.osha.gov/dts/chemicalsampling/toc/chmcas.html)• TOXNET (http://toxnet.nlm.nih.gov/)• ECHA (http://echa.europa.eu/)• EnviChem (www.echemportal.org)

· Notes:CAS Registry Number is a Registered Trademark of the American Chemical Society.CHEMTREC® is a registered service mark of the American Chemistry Council, Inc.

· * Data compared to the previous version altered. This version replaces all previous versions.· Disclaimer:The information contained herein is believed to be true and accurate. However, all statements,recommendations or suggestions are made without any guarantee, representation or warranty, expressor implied, on our part. Therefore, no warranty is made or to be implied that the information set out inthis document is accurate or complete, and we accordingly exclude all liability in connection with the useof this information or the products referred to herein. All such risks are assumed by the purchaser/user.The information contained herein is also subject to change without notice. For the avoidance of doubt,however, nothing in this document excludes or limits our liability for death or personal injury caused byour negligence or for fraudulent misrepresentation.

USA

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SAFETY DATA SHEET FS Hemostatic™ 1. IDENTIFICATION

Product Identifier: 9007057, 9007058 Product name: FS HEMOSTATIC Premier® Dental Products Company 1710 Romano Drive Plymouth Meeting, PA 19462 USA Phone: 610-239-6000 Fax: 610-239-6171 Emergency Phone: 610-239-6000

Restrictions for Use: Professional hemostatic agent Recommended Use: For professional use only. 2. HAZARDS INDENTIFICATION

Classification of the chemical Skin Irritant Cat 2 Eye Irritant Cat 2 Hazard pictogram(s) Exclamation Mark Signal word: Warning

3. COMPOSITION AND INGREDIENTS

Chemical Name: CAS # WT % Classifications Ferric Sulfate 15244-10-7 10-30% Skin Irritant Cat 2

Eye Irritant Cat 2 4. FIRST AID INFORMATION (SYMPTION) Skin contact: There may be mild irritation at the site of contact. Eye contact: There may be irritation and redness. Ingestion: There may be irritation of the throat. Inhalation: No symptoms (ACTION) Skin contact: Wash immediately with plenty of soap and water. Eye contact: Bathe the eye with running water for 15 minutes. Ingestion: Wash out mouth with water. Inhalation: Consult a doctor. 5. FIRE-FIGHTING MEASURES Extinguishing Media: Suitable extinguishing media for the surrounding fire should be used. Use water spray to cool containers. Exposure Hazards: In combustion, emits toxic fumes. Protection of Wear self-contained breathing apparatus. Wear protective clothing to Fire-fighters: prevent contact with skin and eyes. 6. ACCIDENTAL RELEASE MEASURES Personal Precautions: Refer to Section 8 of SDS for personal protection details. Turn leaking containers leak-side up to prevent the escape of liquid. Environmental Precautions: Do not discharge into drains or rivers. Contain the spillage using bunding. Clean-up Procedures: Absorb into dry earth or sand. Transfer to a closable, labeled salvage container for disposal by an appropriate method.

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7. HANDLING AND STORAGE Storage Conditions: Store in cool, well ventilated area. Keep container tightly closed. 8. EXPOSURE CONTROLS / PERSONAL PROTECTION Respiratory Protection: Respiratory protection not required. Hand Protection: Protective Gloves Eye Protection: Safety glasses. Ensure eye bath is at hand. Skin Protection: Protective clothing. 9. PHYSICAL AND CHEMICAL PROPERTIES State: Liquid 10. STABILITY AND REACTIVITY Stability: Stable under normal conditions Conditions to avoid: Heat Materials to avoid: Strong oxidizing agents. Strong acids. Haz. Decomp Products: In combustion, emits toxic fumes. 11. TOXICOLOGICAL INFORMATION Routes of Exposure: Refer to Section 4 of SDS for routes of exposure and corresponding symptoms. 12. ECOLOGICAL INFORMATION Mobilty: Readily absorbed into soil Persistence & Degradability: Biodegradable Bioaccumulative Potential: No bioaccumulation potential Other Adverse Effects: Negligible ecotoxicity 13. DISPOSAL CONSIDERATIONS NB: The user’s attention is drawn to the possible existence of regional or national regulations regarding disposal. 14. TRANSPORT INFORMATION

Product Not classified as dangerous in the meaning of transport regulations

ADR/RID: n/a UN no: - IMDG/IMO: n/a IATA/ICAO: n/a 15. REGULATORY INFORMATION

Risk phrases: R36/38: Irritating to eyes and skin Hazard Statements: H319 Causes serious eye irritation H315 Causes skin irritation Precautionary phrases: P264 Wash thoroughly after handling. P280 Wear protective gloves, protective clothing, eye protections and face protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337 + P313 If eye irritation persists: Get medical attention. P302+P352 IF ON SKIN: Wash with plenty of soap and water. P332+P313 If skin irritation occurs: Get medical attention. P362 Take off contaminated clothing and wash before reuse.

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Note: The regulatory information given above only indicates the principal regulations specifically applicable to the product described in the safety data sheet. The user’s attention is drawn to the possible existence of additional provisions which complete these regulations. Refer to all applicable national, international and local regulations or provisions.

16. OTHER INFORMATION

This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. The user’s attention is drawn to the possible existence of additional provisions which complete these regulations. Refer to all applicable national, international and local regulations or provisions.

Premier’s revision date: 05/18/2015 Revision number: 3

Revision summary: This SDS replaces the September 9, 2010. Revised: Section 1, Section 2, Section 3, Section 14, Section15, Section 16

Supplier’s date: 01/30/2015 This SDS is offered solely for your information, consideration and investigation. This SDS is intended to provide a

brief summary of our knowledge and guidance regarding the use of this material. Premier Dental Products Company provides no warranties; either expressed or implied, and assumes no responsibility for the accuracy or completeness of data contained herein. Premier Dental Products Company urges persons receiving this information to make their own

determination as to the information suitability for their particular application.

121452 Rev3

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POLIDENT DENTURE CLEANSER TABLETS WHITENING

128966 Approved/Revised 15-Aug-2011

Material

SDS Number Version 5

SAFETY DATA SHEET

* 1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

Material Name POLIDENT DENTURE CLEANSER TABLETS WHITENING

Synonym(s) POLIDENT OVERNIGHT SOAK TABLETS, TRIPLEMINT * JAPANESE SMOKERS POLIDENT *

MFC 50077 * DENTURE CLEANING, FORMULATED PRODUCT

Recommended Use Medical Device

Supplier DetailsGlaxoSmithKline UK

980 Great West Road

Brentford, Middlesex TW8 9GS UK

UK General Information (normal business hours): +44-20-8047-5000

GlaxoSmithKline US

5 Moore Drive

Research Triangle Park, NC 27709 USA

US General Information (normal business hours): +1-888-825-5249

Email Address: [email protected]

Website: www.gsk.com

EMERGENCY PHONE NUMBERS -

TRANSPORT EMERGENCIES (by country / geographic region):

Africa / EU / Israel / Middle East (English / European languages): +44 (0) 1235 239 670

Asia Pacific (except China): +65 3158 1074

China: +86 10 5100 3039

Middle East / Africa (Arabic-speaking countries): +44 (0) 1235 239 671

US: +1 703 527 3887

available 24 hrs/7 days; multi-language response

MEDICAL EMERGENCIES: +1 612 221 3999, Ext 221

available 24 hrs/7 days; multi-language response

* 2. HAZARD IDENTIFICATION

Globally Harmonised System Classification & LabellingClassification Reproductive toxicity Category 2

Serious eye damage/eye irritation Category 2

Skin sensitization Category 1

Hazard Symbol(s)

WarningSignal Word(s)

Suspected of damaging fertility. Suspected of damaging the unborn child. Causes serious eye

irritation. May cause an allergic skin reaction.

Hazard Statement(s)

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~Verified on 2014-05 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-05. ~

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POLIDENT DENTURE CLEANSER TABLETS WHITENING

128966 Approved/Revised 15-Aug-2011

Material

SDS Number Version 5

Obtain special instructions before use. Do not handle until all safety precautions have been

read and understood. Use personal protective equipment as required. IF IN EYES: Rinse

cautiously with water for several minutes. Remove contact lenses, if present and easy to do.

Continue rinsing. If eye irritation persists, get medical advice/attention. IF exposed or

concerned: Get medical advice/attention. Dispose of contents/container in accordance with

local regulation.

Precautionary Statement(s)

Other HazardsFire and Explosion Expected to be non-combustible.

Health Not expected to be a significant health hazard unless product is crushed or broken. Exposure

might occur via ingestion; eyes; skin.

Possible effects of overexposure in the workplace include: symptoms of hypersensitivity (such as

skin rash, hives, itching, and difficulty breathing).

Health effects information is based on hazards of components.

Environment No information is available about the potential of this product to produce adverse environmental

effects. This product contains an ingredient(s) that is harmful to aquatic organisms; and may

cause long-term adverse effects in the aquatic environment.

* 3. COMPOSITION / INFORMATION ON INGREDIENTS

EC-No.Ingredients CAS #

201-069-1

Percent

<15

EU Classification

Xi, R3677-92-9CITRIC ACID

1.1 Xi, N, R38, R43, R51, R538006-90-4PEPPERMINT OIL

233-187-410 C, R34, R5210058-23-8POTASSIUM PEROXYMONOSULFATE

208-534-8<3 Xi, R36/37/38532-32-1SODIUM BENZOATE

207-838-8<30 Xi, R36497-19-8SODIUM CARBONATE

217-431-72 Xn, R221847-58-1SODIUM LAURYL SULFOACETATE

234-390-018 Repr. Cat. 2, Repr. Cat. 3, T, Xi,

Xn, O, R61, R62, R22, R23,

R37, R41, R8

10332-33-9SODIUM PERBORATE MONOHYDRATE

20.02Other components below reportable levels

232-752-20.5 Xi, Xn, R52, R42, R37/38, R419014-01-1SUBTILISIN

* 4. FIRST-AID MEASURES

Ingestion Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the

exposed subject is unconscious or semi-conscious. Wash out the mouth with water. If the

exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention.

Inhalation Physical form suggests that risk of inhalation exposure is negligible.

Skin contact Using appropriate personal protective equipment, remove contaminated clothing and flush

exposed area with large amounts of water. Obtain medical attention if skin reaction occurs, which

may be immediate or delayed.

Eye contact Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain

medical attention.

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POLIDENT DENTURE CLEANSER TABLETS WHITENING

128966 Approved/Revised 15-Aug-2011

Material

SDS Number Version 5

NOTES TO HEALTH PROFESSIONALSMedical Treatment Because of the potential for acute or delayed eye damage, consider referral to an

ophthalmologist. Treat according to locally accepted protocols. For additional guidance, refer to

the local poison control information centre.

Medical ConditionsCaused or Aggravated byExposure

New or expectant mothers might be at greater risk from overexposure. Risk assessments must

take this into consideration. Female employees anticipating pregnancy or with a confirmed

pregnancy must be encouraged to notify an occupational health professional or their line

manager. This will act as the trigger for individual re-assessment of the employee's work

practices.

Health SurveillanceProcedures

The need for pre-placement and periodic health surveillance must be determined by risk

assessment. Following assessment, if the risk of exposure is considered significant then exposed

individuals should receive health surveillance focused on detecting skin conditions.

In the event of overexposure, individuals should receive post-exposure health surveillance

focused on detecting skin conditions and adrenal suppression.

Antidotes No specific antidotes are recommended.

5. FIRE-FIGHTING MEASURES

Fire and Explosion Hazards Not expected for the product, although the packaging is combustible.

Suitable Extinguishing Media Water, dry powder or foam extinguishers are recommended. Carbon dioxide extinguishers may be

ineffective.

Special Protective Equipmentand Precautions forFirefighters

For single units (packages): No special requirements needed. For larger amounts (multiple

packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved from

fires involving this product and associated packaging, self contained breathing apparatus and full

protective equipment are recommended for firefighters. If possible, contain and collect firefighting

water for later disposal.

Specific Hazards arising fromthe Material

Toxic, corrosive or flammable thermal decomposition products are expected when the product is

exposed to fire.

6. ACCIDENTAL RELEASE MEASURES

Personal Precautions Wear protective clothing and equipment consistent with the degree of hazard.

Environmental Precautions For large spills, take precautions to prevent entry into waterways, sewers, or surface drainage

systems.

Clean-up Methods Collect and place it in a suitable, properly labelled container for recovery or disposal.

Decontamination Procedures No specific decontamination or detoxification procedures have been identified for this product.

7. HANDLING AND STORAGE

PRECAUTIONS FOR SAFE HANDLINGGeneral Requirements Avoid breaking or crushing tablets.

CONDITIONS FOR SAFESTORAGE

No storage requirements necessary for occupational hazards. Follow product information storage

instructions to maintain efficacy.

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

OCCUPATIONAL EXPOSURE LIMITS

CITRIC ACID ANHYDROUS

1

5000 mcg/m3 (8 HR TWA)

INGREDIENT

GSK Occupational HazardCategory

GSK Occupational ExposureLimit

SODIUM CARBONATE

1

5000 mcg/m3 (8 HR TWA)

INGREDIENT

GSK Occupational HazardCategory

GSK Occupational ExposureLimit

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POLIDENT DENTURE CLEANSER TABLETS WHITENING

128966 Approved/Revised 15-Aug-2011

Material

SDS Number Version 5

SUBTILISIN

5 RESPIRATORY SENSITISER, SKIN

SENSITISER

INGREDIENT

GSK Occupational HazardCategory

POTASSIUM PEROXYMONOSULFATE

3 CORROSIVE

INGREDIENT

GSK Occupational HazardCategory

PERSONAL PROTECTIVE EQUIPMENTEye Protection Wear approved safety glasses with side shields if eye contact is possible.

Other Equipment orProcedures

Follow all local regulations if personal protective equipment (PPE) is used in the workplace. Wear

appropriate clothing to avoid skin contact. Wash hands and arms thoroughly after handling. An

eye wash station should be available.

9. PHYSICAL AND CHEMICAL PROPERTIES

AppearancePhysical Form Tablet.

10. STABILITY AND REACTIVITY

Chemical Stability This product is expected to be stable.

Conditions to Avoid None for normal handling of this product.

* 11. TOXICOLOGY INFORMATION

Target Organ Effects No specific target organ effects have been identified.

Routes of ExposureOral Toxicity Not expected to be toxic following ingestion.

Inhalation Toxicity No studies have been conducted.

Skin Effects Minor irritation might occur following direct contact with damaged skin.

Eye Effects Severe irritation might occur following direct contact with eyes. May cause intense reddening,

swelling and pain with possible irreversible damage to vision.

Sensitisation Allergic skin reactions might occur following dermal exposure. Symptoms of hypersensitivity may

include skin rash, hives, itching, and/or difficulty breathing.

Genetic Toxicity The ingredient sodium perborate monohydrate has caused genetic toxicity in laboratory studies.

However, the relevance of these effects to humans from occupational exposure is not known.

Carcinogenicity No components are listed as carcinogens by GSK, IARC, NTP or US OSHA.

Reproductive Effects The ingredient sodium perborate monohydrate has caused adverse effects on the development of

unborn offspring in animal studies. The ingredient sodium perborate monohydrate has caused

adverse effects to fertility in animal studies.

Other Adverse Effects None known for occupational exposure.

12. ECOLOGICAL INFORMATION

Summary No information is available about the potential of this product to produce adverse environmental

effects. This material contains at least one ingredient that has been tested, and which may be

harmful if released directly to the environment. Consult the MSDS of each ingredient for specific

information about potential environmental effects. Appropriate precautions should be taken to limit

release of this mixture to the environment. Local regulations and procedures should be consulted

prior to environmental release.

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POLIDENT DENTURE CLEANSER TABLETS WHITENING

128966 Approved/Revised 15-Aug-2011

Material

SDS Number Version 5

13. DISPOSAL CONSIDERATIONS

Disposal Recommendations Collect for recycling or recovery if possible. The disposal method for rejected products/returned

goods must ensure that they cannot be re-sold or re-used. The recommended method of disposal

is incineration.

Regulatory Requirements Observe all local and national regulations when disposing of this product.

* 14. TRANSPORT INFORMATION

The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons trained

and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous goods for

transport.

Basic Shipping Description: Not regulated in transport.

* 15. REGULATORY INFORMATION

The information included below is an overview of the major regulatory requirements. It should not be considered to be an exhaustive

summary. Local regulations should be consulted for additional requirements.

EU Classification and LabellingReproductive Category 3, Xn, Xi; R41, R43, R62, R63

Symbol(s) Harmful (Xn)

Risk Phrase(s) R41 - Risk of serious damage to eyes.

R43 - May cause sensitisation by skin contact.

R62 - Possible risk of impaired fertility.

R63 - Possible risk of harm to the unborn child.

Safety Phrase(s) S24/25 - Avoid contact with skin and eyes.

S26 - In case of contact with eyes, rinse immediately with plenty of water and seek

medical advice.

S36/37/39 - Wear suitable protective clothing, gloves and eye/face protection.

S53 - Avoid exposure - obtain special instructions before use.

Classification(s)

US OSHA Standard (29 CFR Part 1910.1200)Classification This product is classified as hazardous according to the OSHA Hazard Communication Standard.

Target Organ Statement No specific target organ effects known.

Other RegulationsTSCA Status Exempt

16. OTHER INFORMATION

References GSK Hazard Determination

SDS Version Number 5

SDS Sections UpdatedSections SubsectionsCOMPOSITION / INFORMATION ON INGREDIENTS

FIRST-AID MEASURES Antidotes

Health Surveillance Procedures

Medical Conditions Caused or Aggravated by Exposure

GHS Classification

HAZARDS IDENTIFICATION

Disposal

Environment

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POLIDENT DENTURE CLEANSER TABLETS WHITENING

128966 Approved/Revised 15-Aug-2011

Material

SDS Number Version 5

SDS Sections UpdatedSections SubsectionsHAZARDS IDENTIFICATION Health

Prevention

Response

IDENTIFICATION OF SUBSTANCE / PREPARATION AND OF

COMPANY

REGULATORY INFORMATION

TOXICOLOGY INFORMATION Eye Effects

Genetic Toxicity

Inhalation Toxicity

Reproductive Effects

Sensitisation

Skin Toxicity

Target Organ Effects

TRANSPORT INFORMATION

The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of issue.

Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine the

applicability of this information and the suitability of the material or product for any particular purpose.

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~Verified on 2014-05 by Henry Schein to be the most current version of the SDS. To be verified again on 2017-05. ~