MVH · Device, Detection, Sulfide

Dental · 21 CFR 872.1870 · Class 2

Overview

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.

Classification Rationale

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.

Special Controls

*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.

In addition to the general controls of the Act, the Diamond General Probe®/Perio 2000 System is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness: (1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) Manufacture of this device is in accordance with recognized voluntary standards of biocompatibility, recognized electrical and electromagnetic standards, and sterilization and sterilization validation standards. (3) Clinical trials demonstrating that the device measures probing depths, evaluates the presence or absence of bleeding on probing, as well as detecting the presence of sulfides in periodontal pockets in the evaluation of periodontal diseases in adult patients. (4) The labeling must include precautions indicating the need (i) to read and understand all directions before using this device, (ii) store probe tips and solutions under proper conditions, (iii) to properly sterilize the probe handle, (iv) to maintain and handle the instrument in a proper manner and condition, and (v) to discard the probe tip after each clinical appointment, when pre-use sterility of the probe tip is considered to be compromised, or after using the system checking substance.

Recent Cleared Devices (1 of 1)

Top Applicants

• Diamond General Development Corp. — 1 clearance