[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: 21CFR872.3540]

[Page 323]
 
                        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. 872.3540  OTC denture cushion or pad.

    (a) Identification. An OTC denture cushion or pad is a prefabricated 
or noncustom made disposable device that is intended to improve the fit 
of a loose or uncomfortable denture, and may be available for purchase 
over-the-counter.
    (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.
    (2) Class II if the OTC denture cushion or pad is made of a material 
other than wax-impregnated cotton cloth or if the intended use of the 
device differs from that described in paragraph (b)(1) of this section. 
The special controls for this device are FDA's:
    (i) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical--Devices Part I: Evaluation and Testing,' '' and
    (ii) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2315, 2000; 65 FR 
17144, Mar. 31, 2000]