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Minimal Class 1 & 2 restorations, deciduous teeth restorations, core build-ups, restorations where opacity is desirable, root surface restorations, Class 5 restorations in nonaesthetic situations, base material for composite restorations, pit and fissure sealant, and semi-permanent fillings.

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The provided text is a 510(k) premarket notification letter from the FDA for a dental cement called Riva Silver. It primarily addresses the regulatory approval process and states that the device is substantially equivalent to legally marketed predicate devices.

This document focuses on regulatory approval based on substantial equivalence and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics. Therefore, I cannot provide the requested information.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

To answer your questions, I would need a document that details the specific performance studies conducted for Riva Silver, including acceptance criteria, study design, results, and ground truth establishment. This 510(k) clearance letter does not include such details.

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