[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3500]

[Page 322-323]
 
                        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. 872.3500  Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.

    (a) Identification. Polyvinylmethylether maleic anhydride (PVM-MA), 
acid copolymer, and carboxymethylcellulose sodium (NACMC) denture 
adhesive is a device composed of polyvinylmethylether maleic anhydride, 
acid copolymer, and carboxymethylcellulose sodium intended to be applied 
to the base of a denture before the denture is inserted in a patient's 
mouth to improve denture retention and comfort.
    (b) Classification. Class III.
    (c) Date PMA or notice of completion of a PDP is required. A PMA or 
a notice of completion of a PDP is required to be filed with the Food 
and Drug Administration on or before December 26, 1996 for any 
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and 
carboxymethylcellulose sodium (NACMC) denture adhesive that was in

[[Page 323]]

commercial distribution before May 28, 1976, or that has, on or before 
December 26, 1996 been found to be substantially equivalent to a 
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and 
carboxymethylcellulose sodium (NACMC) denture adhesive that was in 
commercial distribution before May 28, 1976. Any other 
polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and 
carboxymethylcellulose sodium (NACMC) denture adhesive shall have an 
approved PMA or a declared completed PDP in effect before being placed 
in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]