21 CFR 872.3275 - Dental cement.

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

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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