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The EM-07 is a cordless handpiece with apex localization capability, used for driving files in both continuous rotation and reciprocating mode during an endodontic procedure for enlargement of root canals, while monitoring the position of the endodontic file tip within the canal.

The EM-07 is a cordless handpiece with apex localization capability.

This document is an FDA 510(k) clearance letter for a dental handpiece, not a study report. It states that the device, EM-07 Cordless Endo Motor, has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The standard content of an FDA clearance letter focuses on regulatory approval rather than detailed performance study results.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report submitted to the FDA for review.

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