1. Regulations
  2. title 21
  3. chapter I-i7
  4. part 872
  5. subpart D
  6. § 872.3110

View all text of Subpart D [§ 872.3060 - § 872.3980]

§ 872.3110 - Dental amalgam capsule.

(a) Identification. A dental amalgam capsule is a container device in which silver alloy is intended to be mixed with mercury to form dental amalgam.

(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.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, 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 872.3110