[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: 21CFR872.3285]

[Page 315-316]
 
                        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. 872.3285  Preformed clasp.

    (a) Identification. A preformed clasp or a preformed wire clasp is a 
prefabricated device made of austenitic alloys or alloys containing 75 
percent or

[[Page 316]]

greater gold and metals of the platinum group intended to be 
incorporated into a dental appliance, such as a partial denture, to help 
stabilize the appliance in the patient's mouth by fastening the 
appliance to an adjacent tooth.
    (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]