Nobel Biocare Distributes Updated Information to Regulatory Bodies and Customers On NobelDirect and NobelPerfect One-Piece Implant


ZURICH, Switzerland, Jan. 31, 2008 (PRIME NEWSWIRE) -- The Swedish Medical Product Agency (MPA) and Nobel Biocare (Other OTC:NBCHF) have agreed the wording of a field safety notice, which will be issued today to all regulatory bodies worldwide and to Nobel Biocare customers. The field safety notice is a consequence of clarifications and changes needed to the Instruction For Use.

The following statements are part of the enclosed field safety notice:

"The investigation showed that, on average, the marginal bone level around NobelDirect(tm) was normal and did not deviate from what is typically seen around conventional two-piece implants"..."However, some cases were identified where a lower than expected marginal bone level was observed. These cases were analyzed and the conclusion was that the implants were not placed according to the intended protocol. To avoid these problems, clarifications in the instructions for use were found necessary."

The field safety notice further states:

"There is no potential hazard associated with the continued use of the NobelDirect(tm) and NobelPerfect(tm) one-piece implant to the patients, provided the instructions are followed."

Nobel Biocare has over the last months provided the requested information in relation to the mentioned products, including 3-year follow-up data from the prospective multicenter study on NobelDirect(tm). Nobel Biocare will continue to collaborate with the MPA to seek to close the case.

NobelDirect(tm) and NobelPerfect(tm) one-piece implant are sold worldwide and represent approximately 1% of Nobel Biocare sales.

Nobel Biocare is a medical devices group and the world leader in innovative esthetic dental solutions with its brands Branemark System(r), NobelReplace(tm), NobelSpeedy(tm), NobelPerfect(r), NobelDirect(r), Replace Select (dental implants), Procera(r) (individualized dental prosthetics), NobelGuide(tm) (complete patient rehabilitation program) and NobelSmile(tm) (patient education and awareness program). Nobel Biocare is a total solution provider for restorative esthetic dentistry, offering a wide range of innovative Crown & Bridge & Implant products, as well as training and education, patient information and clinically documented treatment concepts. Nobel Biocare has over 2,200 employees and recorded revenue of EUR 601 million in 2006. The Company is domiciled and headquartered in Zurich, Switzerland. Production takes place at five production sites located in Sweden, USA and Japan. Nobel Biocare has direct sales organizations in 35 countries. The shares of the parent company Nobel Biocare Holding AG are listed on SWX Swiss Exchange and OMX Stockholm, Sweden. /


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