Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 872 - DENTAL DEVICES
/ Subpart D - Prosthetic Devices / § 872.3360 Preformed cusp.
§ 872.3360 Preformed cusp.
(a) Identification. A performed cusp is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be used as a temporary cusp (a projection on the chewing surface of a tooth) to achieve occlusal harmony (a proper bite) before permanent restoration of a tooth.
(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.