(76 days)
Korlex-GRTM is intended for the temporary retraction and hemostasis of the gingival margin during dental procedures when sulcus widening is needed.
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The provided text is a 510(k) premarket notification letter from the FDA to Biotech One, Incorporated, regarding their device Korlex-GR™. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request for the detailed table and study information based on this input. The letter primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also outlines general regulatory compliance requirements.
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