[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3330]

[Page 316]
 
                        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. 872.3330  Preformed crown.

    (a) Identification. A preformed crown is a prefabricated device made 
of plastic or austenitic alloys or alloys containing 75 percent or 
greater gold and metals of the platinum group intended to be affixed 
temporarily to a tooth after removal of, or breakage of, the natural 
crown (that portion of the tooth that normally protrudes above the 
gums). It is intended for use as a functional restoration until a 
permanent crown is constructed. The device also may be intended for use 
as a functional restoration for a badly decayed deciduous (baby) tooth 
until the adult tooth erupts.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994]