[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: 21CFR872.1870]

[Page 313]
 
                        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 B--Diagnostic Devices
 
Sec. 872.1870  Sulfide detection device.

    (a) Identification. A sulfide detection device is a device 
consisting of an AC-powered control unit, probe handle, probe tips, 
cables, and accessories. This device is intended to be used in vivo, to 
manually measure periodontal pocket probing depths, detect the presence 
or absence of bleeding on probing, and detect the presence of sulfides 
in periodontal pockets, as an adjunct in the diagnosis of periodontal 
diseases in adult patients.
    (b) Classification. Class II (special controls) prescription use in 
accordance with Sec. 801.109 of this chapter; conformance with 
recognized standards of biocompatibility, electrical safety, and 
sterility; clinical and analytical performance testing, and proper 
labeling.

[63 FR 59717, Nov. 5, 1998]