(77 days)
Ultra-Blaster is an autoclavable clinical sandblaster for:
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Sandblasting of metal surfaces prior to cementation of crown and inlays, bridges, . Maryland bridges.
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Sandblasting to remove residual cement from crowns and bridges. .
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Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluric acid for add-on repairs.
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Sandblasting of orthodontic bands removes cement and enhances bonding. .
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Acrylic facings can be restored by sandblasting and using a direct metal adhesive. .
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Sandblasting of endodontic posts prior to cementation. .
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Sandblasting of all surfaces to be bonded. .
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Ultra-Blaster" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter merely states that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's safety and effectiveness were established by demonstrating equivalence to an existing device, rather than through a new clinical study.
Therefore, I cannot provide the requested information based on the document provided. A 510(k) submission typically includes performance data, but the clearance letter itself is a summary of the FDA's decision, not the full submission.
§ 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.”