§872.3360. Preformed cusp.
21 C.F.R. § 872.3360
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]