Search Results

Suitable for use in non-load bearing Class I and II restorations, Class V restorations, paediatric and geriatric applications, core build-ups, root surface restorations and semipermanent fillings.

Also suitable for use as a base material for Class I and II cavities using the sandwich technique with composite restorations.

Not Found

This document is a 510(k) clearance letter from the FDA for a dental cement called "Riva Self Cure." It states that the device is substantially equivalent to legally marketed predicate devices.

The information requested regarding acceptance criteria and study details for device performance cannot be found in this document. This letter primarily focuses on the FDA's determination of substantial equivalence based on the provided 510(k) submission, not on presenting detailed performance study results or acceptance criteria.

The 510(k) process typically involves demonstrating substantial equivalence to a predicate device, often through performance testing, but the specifics of that testing (acceptance criteria, study design, results) are contained within the full 510(k) submission, not summarized in the clearance letter itself.

Therefore, I cannot provide the requested table or answer the specific questions about the study from the provided text.

Ask a specific question about this device