[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: 21CFR872.3500]

[Page 318]
 
                        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 
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]