21 CFR 872.6475 - Heat source for bleaching teeth.

Regulations last checked for updates: Nov 25, 2024

Title 21 - Food and Drugs last revised: Nov 21, 2024

View all text of Subpart G [§ 872.6010 - § 872.6890]

§ 872.6475 - Heat source for bleaching teeth.

(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]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

cite as: 21 CFR 872.6475