(288 days)
MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations. MicroJet System is intended as an ancillary device for removing tooth structure, and restorative dental materials as well as preparing teeth for dental restoration.
MicroJet System is an AC-powered cavity preparation device. The device uses air-driven particles to roughen the surfaces of dental restorations.
This document is a marketing clearance letter from the FDA for a dental device, the Microjet Cavity Preparation System. It is not a study report and therefore does not contain the detailed information requested regarding acceptance criteria and study results.
The letter confirms that the device is "substantially equivalent" to devices marketed prior to 1976. This determination is based on a 510(k) submission, which typically involves demonstrating equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as would be found in a research paper.
Therefore, I cannot provide the requested information based on 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.”