21 CFR § 872.3275 - Dental cement.

---
identifier: "/us/cfr/t21/s872.3275"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.3275 - Dental cement."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.3275"
section_name: "Dental cement."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "872"
part_name: "DENTAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 30097, Aug. 12, 1987, unless otherwise noted."
cfr_part: "872"
---


# 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]