[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3100]

[Page 341]
 
                        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. 872.3100  Dental amalgamator.

    (a) Identification. A dental amalgamator is a device, usually AC-
powered, intended to mix, by shaking, amalgam capsules containing 
mercury and dental alloy particles, such as silver, tin, zinc, and 
copper. The mixed dental amalgam material is intended for filling dental 
caries.
    (b) 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 the limitations in Sec. 872.9.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38797, July 25, 2001]