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Desensitizing dentin surfaces by occluding dentin tubules with A mixture of 2 Liquids, Use under crowns And Gridges before cementation, OR for treating cervical Class V erosiono.

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I am sorry, but based on the provided document, I cannot answer questions about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "GREEN-OR Dentin Desensitizer," indicating that the device has been found substantially equivalent to a legally marketed predicate device.

This type of document primarily confirms regulatory clearance for marketing based on substantial equivalence, rather than detailing specific performance acceptance criteria or the results of a stand-alone clinical study that proved those criteria were met. The letter does not contain information on:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or ground truth establishment for any studies.
• Details about expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
• Information on standalone algorithm performance or training set details.

To obtain such information, one would typically need to review the original 510(k) submission summary or other supporting documentation, which is not included in this extract.

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