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Racegel™ is a gel containing aluminium chloride which is intended for sulcus retraction prior to impression taking; control of bleeding and gingival oozing, particularly in restorative dentistry; and, if using a gingival retraction cord, the gel facilitates the insertion of the cord into the sulcus.

Racegel™ is a gel containing aluminium chloride.

The provided document is an FDA 510(k) clearance letter for a dental product called Racegel™. This document does not describe acceptance criteria or a study proving that a device meets acceptance criteria. Instead, it is a regulatory document stating that the product is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the input document. The document primarily focuses on regulatory approval and indications for use, not on performance studies or acceptance criteria comparisons.

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