ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1

• K Number: K964145
• Device Name: ABRADENT MICRO ABRASIVE SANDBLASTER MODEL DV-1
• Manufacturer: CRYSTAL MARK, INC.
• Date Cleared: 1996-12-31 ( 75 days)
• Product Code: KOJ
• Regulation Number: 872.6080
• Type: Traditional
• 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

§ 872.6080 Airbrush.

(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”