[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3400]

[Page 328-329]
 
                        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. 872.3400  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. (1) Class I (general controls) if the device 
contains less than 12 percent by weight of sodium borate. The class I 
device is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to Sec. 872.9.
    (2) Class III if the device contains 12 percent or more by weight of 
sodium borate.

[[Page 329]]

    (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.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50706, Sept. 27, 1996; 
65 FR 2315, Jan. 14, 2000]