21 C.F.R. § 872.6475

Heat source for bleaching teeth.

Last amended: 2016Year: 2026Length: 88 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 872.6475 (2026)

(a) Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent. (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. [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001]
Cross-references to the CFR
872.9.
21 C.F.R. § 872.6475: Heat source for bleaching teeth. | Justis AI