Dental devices; dental noble metal alloys and dental base metal alloys; designation of special controls. Final rule.
The Food and Drug Administration is amending the identification and classification regulations of gold-based alloys and precious metal alloys for clinical use and base alloys devices in order to designate a special control for these devices. FDA is also exempting these devices from premarket notification requirements. The agency is taking this action on its own initiative. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance documents that would serve as special controls for these devices.
D000497:Alloys / Q000145:classification*; D002857:Chromium / Q000145:classification; D003035:Cobalt / Q000145:classification; D003748:Dental Equipment / Q000145:classification*; D017266:Dental Prosthesis / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D006046:Gold / Q000145:classification*; D006801:Humans; D009532:Nickel / Q000145:classification; D010165:Palladium / Q000145:classification*; D010984:Platinum / Q000145:classification*; D011356:Product Labeling / Q000145:classification* / Q000331:legislation & jurisprudence; D012834:Silver / Q000145:classification*; D014481:United States; D014486:United States Food and Drug Administration
D000497:Alloys; D002857:Chromium; D003035:Cobalt; D012834:Silver; D010984:Platinum; D010165:Palladium; D006046:Gold; D009532:Nickel