§872.3590. Preformed plastic denture tooth.
21 C.F.R. § 872.3590
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.
Classification. Class II (special 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 84 FR 71812, Dec. 30, 2019]
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 84 FR 71812, Dec. 30, 2019]