Search Results

• An adjunct device to be used for short-term pain relief from muscle spasm pain due to occlusal interference.
• Prescription device.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "BEST BITE™ Discluder". This document is a regulatory approval, and it does not contain any information regarding acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to the device's efficacy or performance characteristics.

The letter states that the device has been determined to be "substantially equivalent" to legally marketed predicate devices, meaning it has similar intended use, technological characteristics, and safety and effectiveness. This determination is based on the information provided in the 510(k) premarket notification, which would have included data to support substantial equivalence. However, the details of that supporting data are not present in this letter.

Therefore, I cannot extract the requested information from the provided document.

Ask a specific question about this device