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LuxaBite is indicated for use as a bite registration material for use in the production of crowns, bridges and dentures, and in orthodontic treatments. It may also be used as a provisional crown & bridge material.

The LuxaBite dental bite registration material is composed of glass fillers in a matrix of multifunctional methacrylates. This quick setting material is provided in automixing cartridges, and can be dispensed directly onto the teeth. The material has a total working time of 45 seconds. LuxaBite sets up to a firm consistency with a slight amount of elasticity, and may be removed from the teeth within 2-1/2 minutes.

This 510(k) submission for LuxaBite, a dental bite registration material, indicates that no performance or safety data was included in the premarket notification. Therefore, this document does not contain information on acceptance criteria or a study proving the device meets those criteria.

The submission explicitly states under the "Safety and Performance" section: "Substantial equivalence for this device was based solely on design and technical specifications; no performance or safety data was included in this premarket notification."

Consequently, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance, or ground truth establishment based on the provided text. The submission relies entirely on a claim of substantial equivalence to predicate devices based on design and technical specifications.

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