21 C.F.R. § 872.3275

Current through March 31, 2024
Section 872.3275 - Dental cement
(a)Zinc oxide-eugenol -
(1)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.
(2)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 .
(b)Dental cement other than zinc oxide-eugenol -
(1)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.
(2)Classification. Class II.

21 C.F.R. §872.3275

52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2314, Jan. 14, 2000