Business · 07/10/1998

FDA Proposes to Reclassify Endosseous Dental Implant Accessories from Class III to Class I

The FDA is proposing to reclassify certain endosseous dental implant accessories from Class III to Class I, exempting them from premarket notification requirements, based on new information and in accordance with the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.