Code of Federal Regulations Title 21. Food and Drugs § 21.872.3400 Karaya and sodium borate with or without acacia denture adhesive

(a) Identification. A karaya and sodium borate with or without acacia denture adhesive is a device composed of karaya and sodium borate with or without acacia intended to be applied to the base of a denture before the denture is inserted into patient's mouth to improve denture retention and comfort.

(b) Classification.

(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 karaya and sodium borate with or without acacia 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 karaya and sodium borate with or without acacia denture adhesive that was in commercial distribution before May 28, 1976. Any other karaya and sodium borate with or without acacia denture adhesive shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.