[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: 21CFR872.3480]

[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. 872.3480  Polyacrylamide polymer (modified cationic) denture adhesive.

    (a) Identification. A polyacrylamide polymer (modified cationic) 
denture adhesive is a device composed of polyacrylamide polymer 
(modified cationic) 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 
polyacrylamide polymer (modified cationic) 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 
polyacrylamide polymer (modified cationic) denture adhesive that was in 
commercial distribution before May 28, 1976. Any other polyacrylamide 
polymer (modified cationic) denture adhesive shall have an approved PMA 
or a declared completed PDP in effect before being place in commercial 
distribution.

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