On June 25, 2007 the Swedish Medical Products Agency (MPA) published its review of Nobel Biocare's plan to improve information regarding its NobelDirect and NobelPerfect dental implants. The agency stated that the Company needs to provide more information than what Nobel suggested in its reply to the MPA's original ruling on December 6, 2006. MPA reiterated that Nobel is not allowed to actively market either implant (but can continue to sell) until it gets clearance from the MPA. Nobel has until August 20, 2007 to respond with its revised product label.
The MPA is suggesting four main revisions to the product information:
1) Measures to avoid bone resorption (Vertical Positioning): they must state that the implants should be placed so that the first thread is in level with the alveolar bone crest.
2) Measures to avoid bone resorption (Torque): they must indicate when the preparation of the abutment can be seen to require a certain level of torque, above which the two-part implant system should be choosen.
3) Dentist qualifications: devices should be implanted by experienced professionals.
4) General disclosures: repeat the warnings and cautionary measures texts, found in the general instructions for use, in an appropriate way.
Analysts estimate that the NobelDirect and NobelPerfect represent approximately 2% of Nobel's total sales.
