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Temphase is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.

Temphase temporary crown and bridge material is a two component, catalyst and base, material dispensed and mixed by a cartridge/static mixing tip combination. Temphase 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. Temphase contains methacrylate components and is radiopaque for easy radiographic identification.

The provided text describes a 510(k) premarket notification for a dental device, "Temphase," a temporary crown and bridge restorative material. The submission focuses on demonstrating substantial equivalence to a predicate device, not on specific performance criteria or a study proving those criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found in the provided text.

The document is a regulatory approval letter and a summary of safety and effectiveness for a medical device. It attests that the device is substantially equivalent to existing products, thereby allowing it to be marketed. It does not contain the detailed study results or performance data that would typically be required to answer the questions posed.

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