21 C.F.R. § 872.3275 Dental cement.
Title 21 - Food and Drugs
(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. [52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2314, Jan. 14, 2000]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§ 872.3275 Dental cement.
