[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3275]

[Page 327]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 872--DENTAL DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 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 Sec. 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]