[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3490]

[Page 322]
 
                        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. 872.3490  Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.

    (a) Identification. A carboxymethylcellulose sodium and/or 
polyvinylmethylether maleic acid calcium-sodium double salt denture 
adhesive is a device composed of carboxymethylcellulose sodium and/or 
polyvinylmethylether maleic acid calcium-sodium double salt 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 I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter subject to the limitations in Sec. 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 
FR 38798, July 25, 2001]