§872.3275. Dental cement.
21 C.F.R. § 872.3275
Zinc oxide-eugenol—
Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.
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 § 872.9.
Dental cement other than zinc oxide-eugenol—
Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.
Classification. Class II.
Notes, amendments, and revision history
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2314, Jan. 14, 2000]
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
[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2314, Jan. 14, 2000]