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Fill-In is a chemically catalyzed, highly filled, resin-based restorative material used to fabricate short and long term crown and bridge temporaries.

Fill-In temporary crown and bridge material is a two-component, catalyst and base, material dispensed and mixed in both Unidose™, single use syringe, and cartridge delivery. Fill-In is intended for use in both short and long term crown and bridge temporaries. The material is compatible with light cured composites for repair and characterization. Fill-In contains methacrylate components and is radiopaque for easy radiographic identification.

The provided text is a 510(k) summary for a dental device called "Fill-In," a temporary dental restorative material. It focuses on establishing substantial equivalence to a predicate device (Luxatemp Automix Plus) based on intended use and similar function.

This document does not contain information about specific acceptance criteria, performance metrics, or study details such as sample sizes, expert ground truth establishment, or comparative effectiveness studies (MRMC, standalone algorithm performance). The document is a regulatory submission for premarket notification, not a clinical study report or a technical performance evaluation.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them from the provided text.

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