Search Results

Ask a specific question about this device

RESICEM is a dual cured, visible light cured, and self cured dental adhesive resin cement and is intended for adhesion between any two of the following: dental restoration, dental restorative material, dental device, and natural teeth.

Not Found

This document is a 510(k) premarket notification letter from the FDA for a dental cement called ResiCem. It determines that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

The document does not contain information about:

• Acceptance criteria and reported device performance: While it states the device is "substantially equivalent," it does not provide specific performance metrics or acceptance criteria used to reach this conclusion.
• Study details: There is no mention of any specific studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. This type of detailed study information is not typically included in the 510(k) clearance letter itself, but rather in the full 510(k) submission which is not provided here.

Therefore, I cannot provide the requested table or answer the specific questions about the study from the provided text. The document is essentially an approval letter, not a scientific study report.

Ask a specific question about this device