Medical Products Agency’s assessment: additional information on dental implants is required
Monday, June 25, 2007
The Medical Products Agency has now reviewed Nobel Biocare’s plan to improve the information on the dental implants NobelDirect and NobelPerfect. The Medical Products Agency’s assessment is that the instructions for use require more information in addition to the measures that the company has suggested.
During 2006, the Medical Products Agency reviewed the dental implants NobelDirect and NobelPerfect from Nobel Biocare. The reason was because an increased danger for breaking down the alveolar bone was noted. The investigation showed that the instructions for use for the implant were inadequate. Thus the Medical Products Agency demanded that Nobel Biocare improves the instructions.
The Medical Products Agency has now reviewed the company’s plan for improvement of the information on the dental implants and takes the decision that the information must be supplemented and further clarified.
Until Nobel Biocare has carried out the work with the informational activities according to the Medical Products Agency’s instructions for additional information, the company may not actively market the implants NobelDirect and NobelPerfect.