To Canadian Customers of Implant Direct and Nobel Biocare:

In the face of this clarification by Health Canada, Nobel Biocare's continued strategy of misinforming its customers with emails such as that reproduced below, exposes the depths to which Nobel is prepared to go to protect its Canadian sales of overpriced products.

From: John.Meredith@nobelbiocare.com [mailto:John.Meredith@nobelbiocare.com]

Sent: Thursday, October 29, 2009 6:07 PM
Subject: Health Canada Recall - an FYI

Dear Customer:
As a client of NobelBiocare … I do feel obligated to inform you of a significant recall posted by Health Canada. For the past few years, generic implant companies have put forward offerings, self-described as "the same" or "equal in quality at a fraction of the cost". Based on their claims, one would expect to not have to worry about sterility, packaging or product quality that the industry prides it’s self on. Right? By clicking on the following link, you can view the recall by Health Canada in relation to Implant Direct products - page 25 of the pdf. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_manu-fab_july-sept_2009-eng.php

Mr. Meredith's email to Canadian dentists was sent out a week after Implant Direct published on its website the Official Notice of Satisfaction from Health Canada and months after Implant Direct made Nobel Biocare's Management aware of the very limited scope of the voluntary recall, now fully described below in the Health Canada update, posted November 9, 2009.

Reason for Recall:

"Cover caps exhibited visible cracks post sterilization. Testing indicates the integrity
of the packaging was maintained by an inner o-ring seal. The date range of distribution
for the affected products is 2007/04/26 to 2007/08/01."

Nobel's involvement in the initiation of the Health Canada investigation that resulted in the recall is highly suspect. While negotiating with Nobel, Ms. Adele Fussi, former Director of Operations for Implant Direct, shared confidential information with Nobel and used this information to initiate the Health Canada investigation that resulted in the Voluntary Recall. Within 4 days after she filed a questionable report with Health Canada, Ms. Fussi received an employment contract with Nobel for substantially more than her previous salary at Implant Direct. The same day, she revealed that one of the responsibilities of her new job at Nobel was to "spend time with all of Nobel's sales managers, targeting Implant Direct's key accounts, and to teach Nobel's employees to best use the cracked vial information to sell against Implant Direct." Ms. Fussi and Mr. Meredith have since visited Implant Direct's customers as part of their campaign to discredit Implant Direct. She is being sued for stealing confidential information and making false statements. Nobel Biocare has been warned by Implant Direct's attorney to cease misrepresenting the posting on Health Canada's website.

Mr. Meredith's email to Nobel's customers is misleading for the following reasons:

1. The recall was not "significant" as it was voluntary, only involved a cosmetic micro-crack, was limited in time to a few months in 2007 and only resulted in 7 implant vials being exchanged.
    
2. Implant Direct does not represent that its tri-lobe implants are "the same" or "equal in quality." We claim that our RePlant Implant is surgically and prosthetically compatible with the NobelReplace Groovy implant but that it is also stronger (20% by using Titanium Alloy), better designed (micro-threads, double-lead threads, self-tapping) and of higher precision (less than 1 degree of rotational wobble between the implant and abutment compared to about 3 degrees). Mr. Meredith is correct that Implant Direct offers its implants and abutments at "a fraction of the cost."
    
3. Mr. Meredith's email correctly points out that a dentist buying dental implants for surgical implantation into his or her patients "would expect to not have to worry about sterility, packaging or product quality that the industry prides itself on." He cites to the Health Canada posting of Implant Direct's voluntary recall, falsely implying that this indicates a dentist can not expect this from Implant Direct, and by inference, one can expect this from Nobel Biocare.
    
4. Now that Health Canada has clarified the very limited nature of Implant Direct's recall of products sold in a 14-week period between 2007/04/21 and 2007/08/01 and that, "Testing indicates the integrity of the packaging was maintained by an inner o-ring seal", this demonstrates that dentists can "expect to not have to worry about sterility, packaging or product quality" when purchasing Implant Direct's products.
    
5. Quality and Implant Design Issues: Implant Direct has prepared a document entitled "A Tale of Two Systems" comparing its Legacy3 implant with the original internal hex, conical connection (Niznick US Pat. # 4,960,381 - now expired) to the NobelActive implant with an ill-conceived variation on this design. The problems associated with the NobelDirect and NobelPerfect implants are well documented.

Unfortunately, Nobel's customers do have good reasons for concern about the maintenance of sterility with Nobel's implants. Health Canada and the US-FDA are investigating the lack of seal integrity of Nobel's implant vials labeled as "sterile". Nobel's implants failed a standard dye leak test conducted by an FDA certified laboratory. The significance of FDA requirements for validating seal integrity is explained in a Synopsis of an Analyst's Report on Nobel Biocare's packaging. Implant Direct recently conducted dye leak tests on 7 NobelActive implants and the dye penetration into the vials showed a lack of seal integrity.

NobelActive Implants Fail Standard Dye Leak Test For Sterile Packaging Integrity

Test Procedures:

1. Pictures of each sample were taken from different views before the dye penetration test.
   (Reference Attachment for the comparison before and after dye penetration test).
    

2. Pressure inside the pressure tank was kept at -70+/-5kpa pressure for 10 minutes.
    

3. The samples were submerged into the dye solution at -70+/-5kpa pressure for 1 hour.
    

4. Vacuum was removed and samples were exposed to ambient pressure for 30 seconds.
    

5. Samples were rinsed and carefully examined and pictures were taken.
    

President, Implant Direct LLC
www.implantdirect.com