[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: 21CFR872.3450]

[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. 872.3450  Ethylene oxide homopolymer and/or karaya denture adhesive.

    (a) Identification. Ethylene oxide homopolymer and/or karaya denture 
adhesive is a device composed of ethylene oxide homopolymer and/or 
karaya 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. (1) Class I if the device is made of wax-
impregnated cotton cloth that the patient applies to the base or inner 
surface of a denture before inserting the denture into the mouth. The 
device is intended to be discarded following 1 day's use. 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.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 65 
FR 2315, Jan. 14, 2000]