tt zirconia block - xtceraen.xtcera.com/private/files/20170905/... · 2017. 9. 5. · shenzhen...

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Instructions for Use Properties Biological Properties Item Requirements Test Results Compliance Cytotoxicity Cytotoxicity1 No Cytotoxicity Complied Sensitization Test Not Allowed No Sensitization Complied Oral Mucosa Irritation Test Not Allowed Not Found Complied Acute Systemic Toxicity Test Not Allowed Not Found Complied Genotoxicity Test Not Allowed AMES TEST Gene Multation Test:negative Item Standard Testing Result Bending Strength — — 750Mpa Pre-sintered Density N/A 3.06g/cm³ Sintering Density Density (6.06±0.05) g/cm³ 6.04g/cm³ Vickers Hardness >1200HV 1290HV Chemical Solubility <100μg/cm² 64μg/cm² Linear Thermal Expansion Coefficient (10±0.5x10 K ) 9.91x10 K Thermal Shock Resistence YY0301-1998 Complied Physical Property -6 -1 -6 -1 0197 Specification XTCERA blanks are made from biocompatible zirconiumdioxyde. The yttrium oxide stabilizing protects the material against cracks and increases the tensile and compressive strength. The special grain size allocation inside the material and the added aluminium oxide also result in extra strength during milling and subsequently in clinical use. The outstanding mechanical characteristics, excellent chemical durability and the unbeaten biocompatibility combined with the translucent color predestine XTCERA as the ideal material provider for dental milling systems. Product Form: Disks/blanks/blocks in variety size Material Type: High quality ZrO2 Powder AME TEST :negative In Vitro Mannalian Cell Gene Mutation Test:negative 1.Cold-working Property: High strength & tenacity, wear-proof and stability High-speed operation 2.Translucency: Topmost translucency:49% trasmittance,specially designed for esthetic restoration 3.Expansion Homogeneity: 4.Anti-aging Properties: Excellent ageing resistance Based on 14 years manufacturing experience of zirconia products, It is certain that every part of the block has same expansion coefficient. Not suggested to be used in any case of bridge. Perfect for single unit expecially for incisor teeth, anterior teeth and veneer. Storage: Dry storage. Protect from moisture/humidity. Keep it in an environment of 10-50. 1. Handle with care 2. Set a proper clamping force for the block holder Transportation: Contraindication: Chemical Composition: Zro2+Hfo2 94.0 Y2O3 4.5-6.0 AL2O3 0.2-0.5 Other Oxides 0.2 Features Complied TT Zirconia Block Instructions for Use TUVRheinland R ISO 13485:2003 Precisely Right

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Page 1: TT Zirconia Block - XTCERAen.xtcera.com/Private/Files/20170905/... · 2017. 9. 5. · SHENZHEN XTCERA MEDICAL TECHNOLOGY CO.,LTD. Tel:+86-755 8600 1804 Fax:+86-755 8600 1486 E-mail:xtcera@xianton.com

Instructions for Use

Properties

Biological Properties

Item Requirements Test Results Compliance

Cytotoxicity Cytotoxicity≦1 No Cytotoxicity Complied

Sensitization Test Not Allowed No Sensitization Complied

Oral Mucosa Irritation Test Not Allowed Not Found Complied

Acute Systemic Toxicity Test Not Allowed Not Found Complied

Genotoxicity Test Not Allowed AMES TEST Gene Multation Test:negative

Item Standard Testing Result

Bending Strength — — 750Mpa

Pre-sintered Density N/A 3.06g/cm³

Sintering Density Density (6.06±0.05) g/cm³ 6.04g/cm³

Vickers Hardness >1200HV 1290HV

Chemical Solubility <100μg/cm² 64μg/cm²

Linear Thermal Expansion Coefficient (10±0.5x10 K ) 9.91x10 K

Thermal Shock Resistence YY0301-1998 Complied

Physical Property

-6 -1 -6 -1

0197

SpecificationXTCERA blanks are made from biocompatible zirconiumdioxyde. The yttrium oxide stabilizing protects the material against cracks and increases the tensile and compressive strength. The special grain size allocation inside the material and the added aluminium oxide also result in extra strength during milling and subsequently in clinical use. The outstanding mechanical characteristics, excellent chemical durability and the unbeaten biocompatibility combined with the translucent color predestine XTCERA as the ideal material provider for dental milling systems.

Product Form:Disks/blanks/blocks in variety size

Material Type:High quality ZrO2 Powder

AME TEST :negative In Vitro Mannalian Cell Gene Mutation Test:negative

1.Cold-working Property:High strength & tenacity, wear-proof and stabilityHigh-speed operation

2.Translucency:Topmost translucency:49% trasmittance,specially designed for esthetic restoration

3.Expansion Homogeneity:

4.Anti-aging Properties:Excellent ageing resistance

Based on 14 years manufacturing experience of zirconia products,It is certain that every part of the block has same expansioncoefficient.

Not suggested to be used in any case of bridge.Perfect for single unit expecially for incisor teeth, anterior teeth andveneer.

Storage:Dry storage. Protect from moisture/humidity. Keep it in an environment of 10-50℃.

1. Handle with care2. Set a proper clamping force for the block holder

Transportation:

Contraindication:

Chemical Composition:Zro2+Hfo2 >94.0Y2O3 4.5-6.0AL2O3 0.2-0.5Other Oxides <0.2

Features

Complied

TT Zirconia Block

Instructions for Use

TUVRheinlandR

ISO 13485:2003Precisely Right

Page 2: TT Zirconia Block - XTCERAen.xtcera.com/Private/Files/20170905/... · 2017. 9. 5. · SHENZHEN XTCERA MEDICAL TECHNOLOGY CO.,LTD. Tel:+86-755 8600 1804 Fax:+86-755 8600 1486 E-mail:xtcera@xianton.com

Sintering Steps Temperature(℃) Time(h)

Phase 1 20-900 1.5

Phase 2 900-900 0.5

Phase 3 900-1450 3.0

Phase 4 1450-1450 2.0

Phase 5 1450-800 1.0

Phase 6 800-Natural cooling100 Finished

1. Single Crown

Sintering

Block Clamping

Polishing after Sintering

Every batch of XTCERA zirconia block has gone through a completely sintering test. The sintering methods have a great impact on blocks’ properties, such as translucency, dyeing results, strength, hardness and ageing resistance, which will affect blocks’ final stability. Therefore, please follow the sintering curve of XTCERA’s.

To achieve expected quality, the sintering curves must be followed.

1.Sintering preparation: enough sintering space to avoid deformation.

After dyeing, the restoration must be dried. Do not heat up too quickly for it might result in cracks. Make sure the dust-proof cover is put on the crucible to keep impurity away from restorations

2.After sintering: according to the instruction to lower temperature and take out restorations. Do not reduce furnace temperature too quickly to avoid cracks.

3.The highest temperature: the highest temperature will affect the translucency and dyeing results. Make sure the accurate temperature of every step. Sinter and preserve heat according to the instruction.

It would be better not to polish the restorations after sintering. When needed, please use the 10μm diamond tools and cool with water, and at the same time avoid too much pressure.

The thinner the restorations are, the more caution is needed. The thinner part is supposed to be at least 0.5mm. Do not polish the connection part of bridges and the inner wall of copings.

Remove and polish sharp edges. It is not advisable to blast sand. When needed, it should blast 120μm aluminum oxide under 2bar pressure.

After that, clean the restorations with clear water. Every crown and bridge should go though cracking test with indicator.

Choose correct polishing tools and operation methods in every step.

98mm:it requires clients to mark the position manually every time.

100mm:there is a groove on XTCERA’s blanks, please make sure that the groove and the mark hole of block holder sit in alignment

For the used block, please confirm that it is aimed at the previous position mark to avoid incorrect manufacturing position and empty processing.

Attention:The below requirements apply to all kinds of XTCERA blocks1. The blocks must be clean up before being clamped in the block holder2. Make sure the used blocks are clean to prevent cracking caused by uneven force3. Bulging deformation of block holder is not allowed. The block holder should stop using when it was crashed and deformed.4. When tightening, the screws on the block holder must be tightened evenly. Do not tighten them one by one. This process is aiming at preventing block cracking and tooth fracture caused by uneven force and internal stress.

Note: please employ high-temperature furnace specially designed for denture manufacturing. It is good for ceramics sintering to prolong heating up time and cooling time properly.

The translucency of restorations is closely related to sintering temperature and regular maintenance of sintering furnace. Please follow the below temperature chart.

0 200 400 600 8001000120014001600

2 4 6 8 10 12 14

Single Crown

Time

Temperature

0

Sintering Curve

900℃

1450℃

800℃

100℃

SHENZHEN XTCERA MEDICAL TECHNOLOGY CO.,LTD.

Tel:+86-755 8600 1804Fax:+86-755 8600 1486E-mail:[email protected]:www.xtcera.comAdd:4th F, 1st Building, 2nd Area, HonghualingIndustrial Park, Nanshan District,Shenzhen,China