(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 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]