21 CFR §872.3350

1. (a)Identification. 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.
2. (b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.