[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3520]

[Page 346]
 
                        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. 872.3520  OTC denture cleanser.

    (a) Identification. An OTC denture cleanser is a device that 
consists of material in the form of a powder, tablet, or paste that is 
intended to remove debris from removable prosthetic dental appliances, 
such as bridges or dentures. The dental appliance is removed from the 
patient's mouth when the appliance is cleaned.
    (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]