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The Ultradent Carbon Mask is a procedural mask used to protect the patient and user from microorganisms, fluids and particulates.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Ultradent Carbon Mask." It declares the device substantially equivalent to legally marketed predicate devices.

The information provided does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications, as it is a regulatory clearance document rather than a study report.

Therefore, I cannot provide the requested information from the given input. The document confirms the device's regulatory classification and ability to proceed to market but does not contain the technical study details you've asked for.

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