§ 872.3275. Dental cement.
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/us/cfr/t21/s§ 872.3275·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]