[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: 21CFR872.3140]

[Page 314]
 
                        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. 872.3140  Resin applicator.

    (a) Identification. A resin applicator is a brushlike device 
intended for use in spreading dental resin on a tooth during application 
of tooth shade material.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter. If the 
device is not labeled or otherwise represented as sterile, it is also 
exempt from the current good manufacturing practice regulations in part 
820 of this chapter, with the exceptions of Sec. 820.180, with respect 
to general requirements concerning records, and Sec. 820.198, with 
respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989]