[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: 21CFR872.3165]

[Page 342]
 
                        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. 872.3165  Precision attachment.

    (a) Identification. A precision attachment or preformed bar is a 
device made of austenitic alloys or alloys containing 75 percent or 
greater gold and metals of the platinum group intended for use in 
prosthetic dentistry in conjunction with removable partial dentures. 
Various forms of the device are intended to connect a lower partial 
denture with another lower partial denture, to connect an upper partial 
denture with another upper partial denture, to connect either an upper 
or lower partial denture to a tooth or a crown, or to connect a fixed 
bridge to a partial 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 38797, July 25, 2001]