§872.3530. Mechanical denture cleaner.
21 C.F.R. § 872.3530
Identification. A mechanical denture cleaner is a device, usually AC-powered, that consists of a container for mechanically agitating a denture cleansing solution. The device is intended to clean a denture by submersion in the agitating cleansing solution in the container.
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.
Notes, amendments, and revision history
Amendments
[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]
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
[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]