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The ROTARY MASTER device is a control unit that drives a dc electric micromotor that can be turned on or off by a foot switch. It is intended for use in general dental applications such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay, or filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type attachment of equal speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

The ROTARY MASTER device is a control unit that drives a dc electric micromotor that can be turned on or off by a foot switch. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

The provided text is a 510(k) clearance letter from the FDA for a device named "Rotary Master." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

To answer your request, I would need a scientific study report, clinical trial results, or similar performance data, which are not present in this regulatory clearance document.

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