NobelDirect and NobelPerfect One-piece Implant Marketing Surveillance Closed


ZURICH, Switzerland, Feb. 26, 2008 (PRIME NEWSWIRE) -- The Swedish Medical Product Agency (Laekemedelsverket) has informed that the matter of marketing surveillance for the two products NobelDirect and NobelPerfect one-piece issued on 6 December 2006 is closed.

The Swedish Medical Product Agency had issued a directive related to the marketing surveillance for the above-mentioned products on said date.

The agency has in the meantime reviewed all submitted data and information, in particular the 3-year follow-up, submitted by Nobel Biocare in late 2007, the data submitted by other parties as well as the amended instructions for use for both products.

Based on these data the agency has concluded that the directive issued 6 December 2006 be rescinded and that the marketing surveillance can be closed.

Nobel Biocare is pleased with this outcome and will also in future co-operate closely with the agency for any additional request they may have.

Nobel Biocare Holding AG

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 website). Nobel Biocare is a full-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 666 million in 2007. The Company is domiciled and headquartered in Zurich, Switzerland. Production takes place at five production sites located in Sweden, the USA and Japan. Nobel Biocare has direct sales organizations in 36 countries. The shares of the parent company Nobel Biocare Holding AG are listed on SWX Swiss Exchange and OMX Stockholm, Sweden.


Contact Data