U.S. FDA Medical Device Gold & Stainless Steel Cusp Requirements
FDA Medical Device Definition: A gold or stainless steel cusp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group or stainless steel intended to provide a permanent cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) between the teeth and a removable denture.
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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