DIAMOND PROBE/PERIO 2000 SYSTEM

• K Number: DEN980003
• Device Name: DIAMOND PROBE/PERIO 2000 SYSTEM
• Manufacturer: DIAMOND GENERAL DEVELOPMENT CORP.
• Date Cleared: 1998-07-17 ( 60 days)
• Product Code: MVH
• Regulation Number: 872.1870
• Type: Post-NSE
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 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 § 801.109 of this chapter; conformance with recognized standards of biocompatibility, electrical safety, and sterility; clinical and analytical performance testing, and proper labeling.