CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 872—DENTAL DEVICES > SUBPART D—Prosthetic Devices (§872.3060 to §872.3980) > 872.3480—Polyacrylamide polymer (modified cationic) denture adhesive.

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.

Code of Federal Regulations

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