§872.3100. Dental amalgamator.
21 C.F.R. § 872.3100
Identification. A dental amalgamator is a device, usually AC-powered, intended to mix, by shaking, amalgam capsules containing mercury and dental alloy particles, such as silver, tin, zinc, and copper. The mixed dental amalgam material is intended for filling dental caries.
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 38797, 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 38797, July 25, 2001]