(55 days)
The JETPOLISHER airpolishing unit is intended to be used to remove stubborn stains, plaque and soft debris. Device applications: Routine polishing especially hard to reach areas, polishing prior to enamel etching and bonding techniques, and prior to bonding orthodontic bands and brackets
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I apologize, but this document is a 510(k) clearance letter from the FDA for a dental device called "JetPolisher." It primarily concerns the regulatory approval process and does not contain information about acceptance criteria or a specific study proving the device meets those criteria. The letter confirms substantial equivalence to a predicate device and outlines regulatory compliance requirements.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications as they are not present in the provided text.
§ 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.”