[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.3520]

[Page 318-319]
 
                        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.

[[Page 319]]

    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994]