december 2009 newsletter

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Implant Direct Site Website Tour Video Recent Postings Factory Tour Video Introductory Offers Dr. Niznick's Lecture 2009: The Year Implant Direct Transformed the Implant Industry with True Innovation and Value In 2009, Implant Direct completed its third year of sales operations (after 3 years of product development) with a 60% sales increase over 2008 on a global basis. Implant Direct Int'l now has more than 250 employees with offices in California, Nevada, Vancouver, Zurich and Tel Aviv, as well as distributors in over 30 countries. Our manufacturing facility added 6 new CNC machines to keep up with our expanding sales, taking the total to 33, and we went to 24/7 production taking advantage of our unique ability to run lights-out . Implant Direct is proud to have accomplished this explosive growth during a period of global recession with the major implant companies experiencing sales losses of 10-20%. We did this while maintaining, and in several instances, lowering our list prices on existing products. Implant Direct was also able to launch several new and innovative implant systems (SwissPlant, GoDirect, Legacy3). We anticipate continued growth in 2010 with the software and hardware in place to produce CAD milled bars, image guided surgical templates and zirconium abutments. Implant Direct has on order 4 more CNC Screw Machines for April delivery and we will be operating out of our new 8,000 sq. ft. shipping offices in Las Vegas by January 1, 2010, freeing up space in our Calabasas manufacturing facility to expand our clean room packaging operations. With an average of 15-20 new customers a day in North America alone, Implant Direct's business model of focusing on value, innovations and customer service is proving that our logo "Simply Smarter" applies to our way of doing business and to our customers as well. President, Implant Direct LLC [email protected] www.implantdirect.com Transforming Industry Ad 2009 Journal Advertisements: Legacy1, Legacy2 Legacy3 Ad Legacy3 System Ad RePlant, RePlus, ReActive Ad SwissPlant System Ad Prosthetic Abutment Ad Year In Review February 2009 "RealChoice Comes To Implant Dentistry"

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Page 1: December 2009 Newsletter

Implant Direct Site Website Tour Video Recent Postings Factory Tour Video Introductory Offers Dr. Niznick's Lecture

2009: The Year Implant Direct Transformed the Implant Industry with True Innovation and Value

In 2009, Implant Direct completed its third year of sales operations (after 3 years of product development) with a60% sales increase over 2008 on a global basis. Implant Direct Int'l now has more than 250 employees withoffices in California, Nevada, Vancouver, Zurich and Tel Aviv, as well as distributors in over 30 countries. Ourmanufacturing facility added 6 new CNC machines to keep up with our expanding sales, taking the total to 33,and we went to 24/7 production taking advantage of our unique ability to run lights-out. Implant Direct is proudto have accomplished this explosive growth during a period of global recession with the major implantcompanies experiencing sales losses of 10-20%. We did this while maintaining, and in several instances,lowering our list prices on existing products. Implant Direct was also able to launch several new and innovativeimplant systems (SwissPlant, GoDirect, Legacy3). We anticipate continued growth in 2010 with the software andhardware in place to produce CAD milled bars, image guided surgical templates and zirconium abutments.Implant Direct has on order 4 more CNC Screw Machines for April delivery and we will be operating out of ournew 8,000 sq. ft. shipping offices in Las Vegas by January 1, 2010, freeing up space in our Calabasasmanufacturing facility to expand our clean room packaging operations. With an average of 15-20 new customersa day in North America alone, Implant Direct's business model of focusing on value, innovations and customerservice is proving that our logo "Simply Smarter" applies to our way of doing business and to our customers aswell.

President, Implant Direct [email protected]

Transforming Industry Ad

2009 Journal Advertisements:

Legacy1, Legacy2Legacy3 Ad

Legacy3System Ad

RePlant, RePlus,ReActive Ad

SwissPlantSystem Ad

ProstheticAbutment Ad

Year In Review

February 2009"RealChoice Comes To Implant Dentistry"

Page 2: December 2009 Newsletter

In this issue...

RealChoice comes to Implant DentistrySwissPlant Implants Made AvailableReActive Implants Made AvailableNew Factory Tour And Product Overview Videos

July 2009"Implant Direct Launches Three New Implant Systems"In this issue...

Legacy3 - The Next Generation of the Legacy Line of ImplantsSwissPlant - The Next Generation Straumann Compatible ImplantGoDirect - The Locator™ Attachment Compatible ImplantNew Online Shopping CartShop Floor Efficiency and Technology

September 2009"Nobel Biocare's 'Sterile' Packaging"In this issue...

Medwatch Report Filed On Nobel Biocare's Sterile PackagingImplant System Overview AvailableTransforming The Implant Industry - New Online VideoLegacy3 - ReActive - SwissPlant Implant Line Additions

December 2009"The Year In Review"In this issue...

Transforming the Implant Industry - 2009 AdsNew Catalogs for 4 Complete Systems and New Overview CatalogLaunch of GoDirect Implant For Overdenture RetentionTeeth-in-1Day Procedures with ScrewIndirectLaunch of Legacy 1-2-3 Implant SystemPatent Approved for Micro-thread designEvolution of Tri-Lobe Implant SystemUpdate on Nobel PackagingLaunch of SwissPlant Implant SystemCreation of RealChoice Implant Centers

Implant System Catalogs

Page 3: December 2009 Newsletter

Tri-LobeSystem Catalog

LegacySystem Catalog

Implant SystemOverview

SpectraSystem Catalog

SwissPlantSystem Catalog

Go-Direct 1-Piece Implant (3.0mm, 3.7mm & 4.7mm) with Locator™ Compatible Platform

27 years of History

In 1982, Dr. Gerald Niznick, a member of the AAID since 1971 and recipient of theGershkoff Award, published a 40 page article on the Core-Vent System, documenting thefirst use of osseointegrated implants functioning free-standing to retain a lower overdenture.The article also broke new ground documenting numerous cases of immediate placement ofimplants in extraction sockets with abutments added for bar overdenture restorations.

In 2009, Dr. Niznick's Implant Direct Company will launch the GoDirect 1-piece implantwith a Locator™ compatible platform adding to his Spectra-System line that alreadyincludes the1-Piece ScrewIndirect implant designed for screw-retained bar overdentures and fixed-detachable restorations.

Every dentist placing implants will want to add these cost effective, time-saving implantoptions to his or her practice.

GoDirectImplant Tour

GoDirectImplant Packaging

GoDirectRecent Journal Ad

GoDirect Surgical & ProstheticVideo

GoDirectCatalog Pages

Page 4: December 2009 Newsletter

1982 Two Core-Vent Implants with Cemented Abutmentsdesigned to receive Core-Vent Attachments changed thehistory of Implant Prosthodontics.

2009 Two Go-Direct Implants combine the advantages of theZest Locator™ Attachment with the strength, simplicityand economy of a 1-Piece Implant

ScrewIndirect 1-Piece Implant (3.0mm, 3.7mm & 4.7mm) with Screw-Receiving Platform

ScrewIndirectImplant Tour

ScrewIndirectImplant Packaging

ScrewIndirectRecent Journal Ad

ScrewIndirect Surgical &Prosthetic Video

ScrewIndirectCatalog Pages

ScrewIndirect implants with 2.5mm neckprojecting above

Screw-Receiving platform with retentivegroove for snap-on transfer

Page 5: December 2009 Newsletter

Panoramic radiograph showingScrewIndirect 1-Piece implants

ScrewIndirect implants supporting

Bar Overdenture

Legacy 1-2-3 Implant System

More Information On The Legacy System

Twenty-Three years after Dr. Gerald Niznick introduced the first conical connectionwith an internal hex, Implant Direct Int'l launched the Legacy1, 2 and 3 Systems,expanding the surgical and prosthetic options with the most copied platform in theimplant industry (Niznick US. Pat. #4,960,381 expired October 2007). All three systemsshare the same surgical protocol, color coded prosthetic platform and surfaceoptions of SBM or HA ($25 extra). Dentists make their selection based on cost,which varies based on a choice of fixture-mounts. All three implants provide double-lead body threads for faster insertion and quadruple lead mini-threads near the topfor increased stability and reduced stress concentration in the critical crestal area.All the Legacy Implants are packaged with a surgical cover screw and an extenderfor use as a 2mm healing collar.

"It's as Simple as 1, 2 and 3"

Legacy1 - $125 — 3 Diameters: Designed with an evenly tapered body, "V" threadand two self-tapping grooves over the lower half. The implant is delivered on acolor-coded, plastic carrier for ease of insertion and economy.

Legacy2 - $150 — 4 Diameters: Designed with the coronal 1/3 straight and theapical 2/3rds tapered for maximum bone expansion. Aggressive self-tapping andbone expansion is accomplished with the combination of flat-based, spiral threadsand three deep self-tapping grooves that extend from the start of the taper,converging at the apex. The implant is delivered on a color-coded, titanium alloycarrier which can be used during the restorative phase as a transfer and atemporary abutment.

Legacy3 - $175 — 6 Diameters: Designed with evenly tapered body withprogressively deeper, flat-based "buttress" threads for increased surface area andtwo self-tapping grooves extending half way up the implant. The Legacy3 includes3.2mmD, 4.2mmD and 5.2mmD implants with a platform shifting interface. Theimplant is delivered on a color coded, titanium alloy carrier that can be used as aclosed-tray transfer and a full-contour, preparable abutment.

The Legacy System offers the industry's broadest selection of abutment options thatcan be used with the Zimmer Dental, BioHorizons and MIS implants having thesame lead-in bevel, internal hex platform.

Patent Approved for Micro-thread design

Reasons for Allowance of Claims:

Page 6: December 2009 Newsletter

Micro-Thread Animation

Click to Play

"In regard to the prior art rejection based on Hansson ‘564, the examiner finds applicant's remarkspersuasive and adopts them as his own. Moreover, while mindful of the guidance given in KSRInternational Co. v. Teleflex Inc. 550 US 398 (2007), the Examiner notes that the present claimsrequire more the selection of a particular ratio of threading between proximal and distal regions, butalso require that the pitch and alignment of the threads between the two portions are such that thethreads of the proximal region fit into the jawbone threads formed by the distal region or cut into bonebetween the jawbone threads without cutting across the jawbone threads. The examiner finds theclaimed particular ratios in combination with the required formation of the pitch and alignment betweenthe two portions to be nonobvious."

Implant Direct Mini-thread Design: Double-lead threads on bodyfor faster insertion with Quadruple-lead threads starting 1mmbelow the crest of the bone, creating mini-threads that are 1/2the depth of the body threads. 2 of the 4 mini-threads align withthe threads pre-tapped in the bone by the double-lead bodythreads with the other two self-tap new threads in the peaks ofthe bone threads for increased stability

Astra Mini-thread Design, going from Single-lead threads on thebody with Triple-lead threads starting at the crest of the bone,creating mini-threads that are 1/4 the depth of the bodythreads. Only 1 of the 3 mini-threads aligns with the threadspre-tapped in the bone by the body threads with the other twothreads crushing the peak of the bone threads.

Page 7: December 2009 Newsletter

RePlant™, RePlus™ and ReActive™ Tri-lobe Implants

More Information On The Tri-Lobe System

History of the Tri-lobe Connection:

During the 1980's and 1990's, Nobel Biocare ("Nobel"), through its paid opinion leaders,proclaimed the Branemark External Hex connection as the "gold standard" in spite of awell documented history of screw-loosening and the necessity to take X-rays to confirmfull seating. Dr. Gerald Niznick developed the first internal connection in 1986 (patent #4,960,381 issued in October 1990 and expired 2007) for Core-Vent Corporation’s Screw-Vent™ Implant. Today, almost 24 years later, the Screw-Vent implant with its lead-inbevel and internal hex, is the mainstay of the Zimmer Dental product line. Some majorcompanies, such as Friadent, 3i, BioHorizons, Steri-Oss and Straumann took licenses onthis patent while other U.S. companies were prevented from infringing by enforcement ofthe patent prior to its expiration in October 2007. There are many other companies inIsrael, Europe and South America where the Niznick patent was never filed, who alsoduplicated the original internal connection.

In 1998, Steri-Oss introduced the Replace™ Implant with a tri-lobe, butt-joint connection.Nobel acquired Steri-Oss in 1999 and promoted this internal connection as: "What everydentist wants…an internal connection," acknowledging that its Branemark external heximplant was not what its customers wanted. Nobel received a patent for the Tri-lobeconnection in 2004 preventing competitors from making compatible implants until ImplantDirect launched the RePlant™ System in 2006. Implant Direct’s tri-lobe connection issimilar to and compatible with Nobel’s, including the color coding, but varies by creating asecond set of internal tri-lobes that provide double the length of engagement for theImplant Direct’s multi-functional, titanium fixture-mounts. This improved double tri-lobedesign earned Dr. Niznick his 34th patent, avoided infringement and accepted Nobel’s tri-lobe abutments with as good or better precision fit.

In 2008, Nobel acquired Alpha Bio Tech, an Israeli implant company that built its businessby copying the Screw-Vent Implant system. Today Alpha Bio still sells implants with theNiznick/Screw-Vent internal 44 degree bevel above a hex. Its catalog refers to this designas “the Perfect Implant-Abutment Connection.” After Nobel acquired Alpha Bio, itintroduced the NobelActive™ Implant, similar to Alpha Bio’s SPI spiral thread implant, butwith a 78 degree lead-in bevel above the internal hex. A comparison of the Legacy3 andNobelActive implant demonstrates why the NobelActive connection creates difficulty indetermining by tactile sense alone, if abutments and transfers are fully seated.

In 2007-2008, Implant Direct expanded the RePlant system to include the RePlus™ Implant and ReActive™ Implant, both with the RePlant doubletri-lobe connection. The ReActive and NobelActive Implants provide progressively deeper threads for increased surface area. Unlike theNobelActive, all Implant Direct Implants have micro-threads to reduce bone loss and a round apex to avoid deviating from the established bone

Page 8: December 2009 Newsletter

socket during insertion or tearing the sinus membrane. The ReActive implant was developed to provide Nobel customers with an aggressive threadoption without abandoning the tri-lobe color-coded platform they had become familiar with. Implant Direct’s Legacy™ System provides the originalNiznick lead-in bevel, internal hex connection that provided the tactile sense to eliminate the need to take X-rays to verify full seating. In 2009, itwas expanded to include the Legacy3 with the same body and threads of the ReActive implant.

In 2009, Implant Direct improved the packaging on the RePlant Implant with a two-piece titanium fixture-mount that can be used as a transfer. Thefixture-mount can be shortened for used as a temporary abutment, or for converting a patient's denture in a Teeth-in-1Day™ procedure. ImplantDirect added a Dual Grip configuration to the screws and healing collars of its tri-lobe implants, allowing use of a standard 1.25mm (0.05”) hex toolor Nobel's "Unigrip" tool. These improvements were made without any increase from the $150 launch price of the RePlant Implant. Implant Direct’stri-lobe implant system offers Nobel customers significant cost savings, the convenience of all-in-one packaging and design improvements that havebeen shown to increase clinical success.

The document links below will help you understand why Implant Direct's products offer superior quality, design, clinicalsuccess, packaging and value compared to those sold by Nobel Biocare.

Multi-Center Study ShowsRePlant More Successful

Than Nobel Replace™

"All-on-Four" Case StudyBy Dr. Pedro Pena using

RePlant Implants

A Tale Of Two SystemsComparing Legacy3 To

Nobel Active

Compare Advantages ofRePlant To Nobel's Replace

Tapered Groovy Implant

Compare Advantages ofLegacy3 To Nobel'sNobelActive Implant

Update On Nobel Packaging Response to Nobel's Misleading Marketing in Canada

Dye Penetration Test ResultsNobelActive™ Implant

(NobelActive NP 3.5 x 11mm)

Click image to enlarge

Nobel Biocare's NobelActive implants failed standard dye leak tests required to confirm sealintegrity of products labeled as sterile. Implant Direct's investigation of Nobel Biocare'spackaging was triggered by Nobel's decision to misrepresent Implant Direct's Canadianvoluntary recall of a small quantity of implant vials sold during a 14 week period in 2007.The recall resulted in the exchange of only 7 implant vials and related to cosmetic micro-cracks in the caps. Health Canada Website confirms that "Testing indicates the integrity ofthe packaging was maintained". Nobel's involvement in instigating the recall itself is inquestion because the packaging issue was brought to the attention of Health Canada by adisgruntled Implant Direct employee who went to work for Nobel in July 2009 for theexpressed purpose of using a recall to discredit Implant Direct. That employee was hired inJuly 2009 and let go by the end of November 2009 after Health Canada advised Nobel thatusing recall information for marketing was against their regulations. Nobel's involvement inthis sordid affair triggered a chain of events that has resulted in a Medwatch report beingfiled with the FDA after Nobel's packaging failed standard dye leak tests used to validateseal integrity. The fact that Nobel Biocare circulated false and misleading information aboutthe significance of Implant Direct's voluntary recall while not addressing its own packagingissue exposes the depths to which Nobel was prepared to go to combat the migration of itscustomers to Implant Direct's products.

Health Canada and the FDA have investigations ongoing on Nobel's packaging and labeling issues. Nobel claims that it validates its sterility and/or seal integrityusing a different test than the standard dye leak test but has refused to provide the name of the test or the results to any of the stock analysts who haverequested this information.

According to a Chief Science Officer at an FDA certified testing laboratory: "If a manufacturer sent us packaging samples from a validation (not R&D) for dye immersion, or for that matter any ISO11607 recommended packaging test, andwe saw failures, our approach would be to investigate why the samples were failing, then notify the customer of the nature and location of the failure. We woulddecline to test packaging from the same unmodified process for a different method in an attempt to obtain passing packaging results. That would beselecting data and is unacceptable."

Page 9: December 2009 Newsletter

SwissPlant Dental Implant System

The SwissPlant System represents the first line of implants designed for insertion at tissue-level, bone-level or anywhere in between. Thisis demonstrated in our surgical video. The 4.1mmD and 4.8mmD SwissPlant implants offer surgical compatibility with Straumann's drills insoft bone with an additional drill required for dense bone. The 4.8mmD and 6.5mmD platforms are prosthetically compatible withStraumann's abutments, having the same internal octagon licensed to Straumann by Dr. Niznick (U.S. Patent # 4,960,381) and an 8degree lead-in bevel. In addition, they have an internal square for engagement via the color coded fixture-mount for insertion. The fixture-mount also serves as a transfer and can be shortened for use as the final 5.5mm high straight abutment. Each implant is packaged with asnap-on comfort cap and 2mm healing collar for added value. Adding to the versatility of the SwissPlant System is a 3.3mmD implant witha 3.7mmD platform and a 5.7mmD implant with a 6.5mmD platform, all available in 5 lengths including, a 6 mm long implant. TheSwissPlant implants include micro-threads and progressively deeper flat-based (Straumann) threads, first developed for the ReActiveimplant, providing increased surface area for increased stability in soft bone.

SwissPlant Implant TourClick to Play

SwissPlant Packaging VideoClick to Play

SwissPlant SystemProduct Catalog

SwissPlant Surgical VideoClick to Play

Compare SwissPlantTo Straumann Implants

SwishPlant™, SwishPlus™ and SwishActive™ Implants

Definition: adjective - elegant, smart, perfect Implant Direct Broadens its product offering forStraumann Customers

Straumann, the Swiss Implant Company that pioneered the

Page 10: December 2009 Newsletter

one-stage (tissue-level) implant finally realized that a two-stage (bone-level) implant was also needed for the estheticzone. Pushing the smooth neck sub-crestal to lower themargin increased the probability of bone loss. Apparently theyalso realized the difficulty in selling high priced implants inthese troubled economic times. An article in a Swiss businessmagazine in May 2009 and a more recent article in a Zurichnewspaper made it very clear to Straumann that ImplantDirect represents a price-point shift in the implant industry thatcould no longer be ignored. Instead of responding with betterproducts at better prices, Straumann took issue with thename of Implant Direct's SwissPlant implant system,demanding that it be changed because SwissPlant implantsare not made in Switzerland. Implant Direct had named it'sproduct SwissPlant because of the surgical and prostheticcompatibility with Straumann's tissue-level implant, which hasan internal connection licensed to Straumann in 2000 underthe Niznick Patent #4,960,381. Implant Direct is proud of thefact that it makes all of its products in United States andresponded to Straumann's challenge by changing the productname to SwishPlant. The definition of the adjective "swish" is"smart, elegant or perfect." Having been prompted to changethe name by Straumann, Implant Direct decided to broadenthe Swish™ line to bring even greater surgical versatility andcost savings to Straumann's customers as shown below in thenew Swish-System of products.

Bone-level Implant - $150 – 3 Diameters:

Available in 3.3mmD, 4.1mmD and 4.8mm DiametersConical connection matching the Legacy internal hex platformSurgically compatible with Straumann's Tissue-level implantsSelf-tapping with Micro-threadsFixture-mount is a transfer and temporary abutmentCover-screw and 2mm Healing Collar included

SwishPlant™ Implant Video Tour

Click to Play

Tissue-level Implant - $175 – 3 Diameters:

Available in 4.1mmD and 4.8mmD with Straumann compatiblePlatforms and 3.3mmD with the Legacy internal hex platformSurgically compatible with Straumann's Tissue-level implantsSelf-tapping with Micro-threadsFixture-mount is transfer and straight abutment, with snap-oncomfort cap includedCover-screw and 2mm Healing Collar included

SwishPlus™ Implant Video Tour

Click to Play

Bone- and Tissue- level Implant - $200 – 5 Diameters:

Available in 4.1mmD and 4.8mmD with Straumann compatible

SwishActive™ Implant Video Tour

Page 11: December 2009 Newsletter

Platforms and 3.3mmD with the Legacy internal hex platformSurgically compatible with Straumann's Tissue-level implants in softbone with an additional drill required for dense boneSelf-tapping with double-lead body threads and micro-threadsFixture-mount is a transfer and a straight, preparable abutment witha pre-machined marginCover-screw and 2mm Healing Collar included

Click to Play

The SwishPlant™ bone-level and SwishPlus™ tissue-level implants are surgically compatible with Straumann's Tissue-level Implants. The SwishActive™ is the same body as the current SwissPlant with a different fixture-mount.

Implant Direct Initiates Direct Marketing Strategy For Its Customers Using RealChoice Trademark And Web Site

In these uncertain economic times, dentists need to be proactive in their efforts to expand or even maintain their dental practices.Implant Direct gives you the hardware to offer cost-effective implant treatment and now has developed the marketing strategyavailable at no cost to our customers. Our RealChoice™ implant center program provides you with a free, customized website and adcopy to market your practice under the umbrella of a third party endorsement. Increase your practice revenue through direct toconsumer marketing of implant procedures including Teeth-in-1Day™ for the edentulous upper and lower jaws. With our GoDirect™one-piece implants with a Locator™ compatible platform, you will be able to place 2 implants in the lower jaw to stabilize a denturefor only $400 in hardware costs. With our ScrewIndirect™ one-piece implants with a screw-receiving platform, you will be able toconvert a denture into a fixed-detachable restoration supported by 5 implants for under $1,000 in hardware costs. Visit our websiteand register for additional information on how to become a RealChoice Dental Implant Center.

Read about ClearChoice Implant Centers, their marketing strategy and their efforts toprevent Implant Direct from offering RealChoice Websites to its customers.

Introductory Offers

3 FREE IMPLANTS AND PROSTHETICS

Proof of purchase of implants from an Implant Company listed below is required!Disclaimer: The logos below are the registered trademarks of their respective companies. Implant Direct does not sell products manufacturedby any of these companies.

Click on a Company Logo* For Comparative Information And Suggested Free Implant Offers

Page 12: December 2009 Newsletter

Straumann

These introductory offers are for first time purchasers of implants from Implant Direct. Dentists who did not take advantage of anyintroductory offers on their first purchase may do so within 90 days of their first purchase. One Introductory Offer is provided per dentist,dental office, group practice or partnership regardless of whether the dentist(s) practice in multiple locations.

2009 User SurveyPlease click here to participate in our annual user survey

Call 1-888-649-6425 to speak with a Technical Sales representative. To continue to receive our company newsletter, be sure to add [email protected] to your address book.Implant Direct LLC Customer Service Center., 26330 Diamond Place #100 Santa Clarita, CA, 91350 U.S.A.If you do not wish to receive further emails from us, please click here to unsubscribe.

Locator is a registered trademark of Zest Anchors Inc. - Teeth-In-1Day is a registered trademark of Implant Direct LLC - Screw-Vent is a registered trademark of Zimmer Dental Inc.NobelActive is a registered trademark of Nobel Biocare. Straumann is an international trademark by Institut Straumann AG.