[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: 21CFR872.3350]

[Page 328]
 
                        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. 872.3350  Gold or stainless steel cusp.

    (a) Identification. A gold or stainless steel cusp is a 
prefabricated device made of austenitic alloys or alloys containing 75 
percent or greater gold and metals of the platinum group or stainless 
steel intended to provide a permanent cusp (a projection on the chewing 
surface of a tooth) to achieve occlusal harmony (a proper bite) between 
the teeth and a removable denture.
    (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.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]