[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: 21CFR872.3570]

[Page 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. 872.3570  OTC denture repair kit.

    (a) Identification. An OTC denture repair kit is a device consisting 
of a material, such as a resin monomer system of powder and liquid 
glues, that is intended to be applied permanently to a denture to mend 
cracks or breaks. The device 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
    (2) ``OTC Denture Reliners, Repair Kits, and Partially Fabricated 
Denture Kits.''

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