[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: 21CFR872.3420]

[Page 317]
 
                        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. 872.3420  Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.

    (a) Identification. A carboxymethylcellulose sodium and cationic 
polyacrylamide polymer denture adhesive is a device composed of 
carboxymethylcellulose sodium and cationic polyacrylamide polymer 
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 
carboxymethylcellulose sodium and cationic polyacrylamide polymer 
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 carboxymethylcellulose sodium and cationic 
polyacrylamide polymer denture adhesive that was in commercial 
distribution before May 28, 1976. Any other carboxymethylcellulose 
sodium and cationic polyacrylamide polymer 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]