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Hycem® Aplicap® is intended for final cementation of restorations composed of all classes of materials, including for cementation of crowns, bridges, inlays/onlays, pins and screws, and brackets and bands.

compomer luting cement, tradenamed Hycem® Aplicap®

This 510(k) summary for K963737 describes the Hycem® Aplicap® compomer luting cement. However, the provided text does not contain any information regarding clinical studies, acceptance criteria for device performance, or data related to AI/algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, expert involvement, or ground truth, as none of this information is present in the provided document.

The document focuses on:

• Intended Use: Final cementation of restorations (crowns, bridges, inlays/onlays, pins, screws, brackets, bands).
• Substantial Equivalence Claim: To Dentsply Caulk's Advance™ Hybrid Ionomer Cement, based on similar intended use and composition.
• Performance Claim: Hycem® Aplicap® meets the requirements of relevant DIN and ISO standards for dental cement. This is a general statement about physical properties, not specific clinical performance metrics.

To answer your questions accurately, a document detailing performance studies (clinical or benchtop with specific acceptance criteria) would be required.

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