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The PORTABLE DENTAL HANDPIECE device is a control unit that drives a DC micromotor that can be turned on or off by a foot switch. It is intended for elective dental applications such as cutting a tooth for crown preparation and use in general dental application, inlay or filling finishing, polishing and endodontic treatment, with use of a contra-angle Doriot Style attachment of equal speed. The speed is adjustable by the control panel on the top of the control unit from 1,000 to 25,000 rpm.

The PORTABLE DENTAL HANDPIECE device is a control unit that drives a DC micromotor that can be turned on or off by a foot switch. The speed is adjustable by the control panel on the top of the control unit from 1,000 to 25,000 rpm.

The provided document is a 510(k) premarket notification letter from the FDA for a "PORTABLE DENTAL HANDPIECE." This document does not include information about acceptance criteria, study details, or performance data for the device. Therefore, I cannot extract the requested information.

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

This indicates that the device was approved based on its substantial equivalence to a predicate device, rather than a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text.

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