21 CFR 872.3420 - Carboxymethylcellulose sodium and cationic polyacrylamide polymer denture adhesive.

§ 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]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code