(70 days)
Re/Stasis™ is a paste containing kaolin clay and aluminum chloride, and is intended to be used for the temporary retraction and hemostasis of the gingival margin during dental procedures. These procedures include dental impressions, restorations, seating of temporary and permanent restorations, placement of rubber dam, and other procedures.
Re/Stasis™ is a paste containing kaolin clay and aluminum chloride
This K111348 document is a 510(k) clearance letter from the FDA for a device named Re/Stasis™. This type of document primarily confirms that the device is "substantially equivalent" to a legally marketed predicate device and grants permission to market it. It does not contain acceptance criteria, details of a clinical study, or performance data.
The sections you've asked for (acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are typically found in the submission itself, which is not publicly released in this format, or in a Summary of Safety and Effectiveness Data (SSED) if one were available (which is more common for PMA devices).
Therefore, based solely on the provided text, I cannot answer the specific questions about acceptance criteria and study details. The document states that the device is intended for "temporary retraction and hemostasis of the gingival margin during dental procedures." The FDA's determination is based on substantial equivalence, implying that the safety and effectiveness are considered comparable to an existing device without necessarily requiring new clinical trials to demonstrate specific performance metrics for this particular 510(k) submission.
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