(38 days)
Miniblaster is an autoclavable clinical sandblaster for:
- Sandblasting of metal surfaces prior to cementation of crown and inlays, bridges, . Maryland bridges.
- Sandblasting to remove residual cement from crowns and bridged. .
- Sandblasting of porcelain and resin surfaces prior to bonding and replaces use of . hydrofluoric acid for add-on repairs.
- Sandblasting of orthodontic bands removes cement and enhances bonding. ●
- Acrylic facings can be restored by sandblasting and using a direct metal adhesive. ●
- Sandblasting of all surfaces to be bonded. .
Miniblaster is an autoclavable clinical sandblaster
This document is a 510(k) clearance letter from the FDA for a dental device called "MiniBlaster Clinical Sandblaster." It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These details are typically found in the 510(k) submission summary or other supporting documentation, which is not present here.
Therefore, I cannot provide the requested table and study details based on the input text. The input only indicates the FDA's clearance of the device based on substantial equivalence, and lists its intended uses.
§ 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.”