Search Results

To Reduce dentin sensitivity PRIOR TO cementing CROWNS, Bridges, etc. Also for Reducing dentin sensitivity in Class V CROSTOWSO

Not Found

This document is a 510(k) premarket notification from the FDA regarding the "D/Sense-T" device. It does not contain any information about acceptance criteria, device performance, ground truth, study design, or sample sizes.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only confirms that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices for the stated indications for use (to reduce dentin sensitivity prior to cementing crowns, bridges, etc., and for reducing dentin sensitivity in Class V restorations).

Ask a specific question about this device