Dental Products Devices; Reclassification of Endosseous Dental Implant Accessories

요약

The Food and Drug Administration (FDA) is proposing to reclassify manually powered drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, trial abutments, and other manually powered endosseous dental implant accessories from class III to class I. These devices are intended to aid in the placement or removal of endosseous implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. FDA also proposes to exempt these devices from premarket notification requirements. This reclassification is being proposed on the Secretary of Health and Human Services' own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997