21 CFR 872.3275 - Dental cement.

Beta! The text on the eCFR tab represents the unofficial eCFR text at ecfr.gov.
§ 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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 872 after this date.

  • 2015-11-20; vol. 80 # 224 - Friday, November 20, 2015
    1. 80 FR 72585 - Dental Devices; Reclassification of Electrical Salivary Stimulator System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective December 21, 2015.
      21 CFR Part 872