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The Modified TempRx Esthetic Provisional System is:

• · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months.
• · Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years:
  • Inlays/ Onlays
  • Veneers
  • Crowns
  • 3-unit bridges through the 2nd bicuspid.

· Indicated for the build up of a tooth on denture base resins.

The Modified TempRx Esthetic Provisional System is a visible light cured composite based resin and accessories used to create provisional restorations for patients waiting for final prosthodonic restorations.

The provided text is a 510(k) summary for a dental device, "Modified TempRx Esthetic Provisional System." It focuses on device description, intended use, and technological characteristics compared to predicate devices for regulatory clearance. It does not contain information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory submission for substantial equivalence rather than a detailed performance study report.

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