[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: 21CFR872.3560]

[Page 323-324]
 
                        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. 872.3560  OTC denture reliner.

    (a) Identification. An OTC denture reliner is a device consisting of 
a material such as plastic resin that is intended to be applied as a 
permanent coating or lining on the base or tissue-contacting surface of 
a denture. The device is intended to replace a worn denture lining and 
may be available for purchase over the counter.
    (b) Classification. Class II. The special controls for this device 
are FDA's:
    (1) ``Use of International Standard ISO 10993 `Biological Evaluation 
of Medical Devices--Part I: Evaluation and Testing,' '' and

[[Page 324]]

    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996; 
65 FR 17144, Mar. 31, 2000]