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Dentaurum NO-MIX One Step Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (37.4% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.

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This document is an FDA 510(k) clearance letter for the "Dentaurum NO-MIX One-Step Bracket Adhesive." It is not a study report or a technical document detailing acceptance criteria and performance data from a specific study.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth definitions cannot be extracted from the provided text.

The letter merely states that the device has been found "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new premarket approval application based on its similarity to existing, approved devices. The FDA performs its own review to determine substantial equivalence based on information submitted by the manufacturer, but this letter does not contain those details.

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