21 C.F.R. § 872.6475
Heat source for bleaching teeth.
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.