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The dental slow speed handpiece is a precision instrument used by a dental professional at slow speed (100 to 20,000 rpm) for the removal of carious tissue, the preparation of teeth for restorations, for crowns and bridges, for cosmetic correction, and for the trimming, finishing, and polishing of all types of dental restorations and prostheses. Note: Federal Law restricts the use of this device to dental professionals.

Excel Contra Angle Hand Piece

The provided document is a 510(k) clearance letter from the FDA for a dental handpiece. It primarily addresses the regulatory approval process based on substantial equivalence to a predicate device. It does not contain any information about acceptance criteria or a study proving device performance in the way a clinical or technical performance study report would.

Therefore, I cannot provide the requested information. The document focuses on regulatory classification and general controls, not on specific performance metrics or detailed study results.

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