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Title 21 Part 872 → Subpart D → §872.3275

Title 21 → Chapter I → Subchapter H → Part 872 → Subpart D → §872.3275

Electronic Code of Federal Regulations e-CFR

Title 21 Part 872 → Subpart D → §872.3275

e-CFR data is current as of January 27, 2020

Title 21Chapter ISubchapter HPart 872Subpart D → §872.3275


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices


§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]