21 CFR §872.3590
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)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.
- (b)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.