(181 days)
The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.
The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing.
This document is a 510(k) premarket notification approval letter for the "Airprep System - Model 9001" and does not contain the detailed study information, acceptance criteria, or performance data typically included in a clinical study report. The letter indicates that the device has been determined to be substantially equivalent to previously marketed devices.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval rather than a scientific study report.
§ 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.”