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Tooth colored restorations for proximal cavities prepared with Sonicsys instruments (Class II in the posterior region, Class III in canines)

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Sonicsys Inlay" device. This document does not contain information about acceptance criteria, study details, or performance results in the format requested.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This is a substantial equivalence determination, meaning the device is deemed equivalent to a predicate device already on the market, not a direct evaluation of novel performance against specific acceptance criteria in a study. Therefore, the requested information points (1-9) about acceptance criteria, study design, sample sizes, expert qualifications, adjudication, or standalone/MRMC studies are not available in this document.

The document only provides:

• Device Name: Sonicsys Inlay
• Regulatory Class: II
• Product Code: EIH
• Indications For Use: Tooth colored restorations for proximal cavities prepared with Sonicsys instruments (Class II in the posterior region, Class III in canines)

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