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Super adhesive system for adhering A-silicone and C-silicone impression materials on disposable plastic or light cured custom trays.

It is the intention of S & C Polymer GmbH to manufacture the TRAY-LINK cited above which can be used as adhesive system for adhering silicone impression materials on disposable plastic or light cured custom trays.
The cited TRAY-LINK material S & C Polymer GmbH manufactures for Pharmex and Henry Schein contains a chemistry commonly found in current dental materials.
The purpose of this material for use by the dentist or technician is to build a chemical link between impression materials and the impression trays.
The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483.

This document seems to be a 510(k) premarket notification for a dental adhesive product called TRAY-LINK. It describes the product's purpose, chemical composition, and regulatory information, but it does not contain any information about acceptance criteria, study designs, or performance data for a device in the context of the requested questions.

The provided text focuses on the regulatory submission process and the substantial equivalence to a predicate device (A-Soft Reline K984483). It explicitly states: "The chemical compositions of the key components A-LINK of the TRAY-LINK system are substantially equivalent to the denture priming component A-Soft Prime of the product A-Soft Reline 510(k) K984483." This indicates that the regulatory approval in this case relies on chemical substantial equivalence, not on a new performance study that would generate the kind of data you're asking for.

Therefore, I cannot provide the requested information based on the input text. The questions about acceptance criteria, study design, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth are not addressed in this 510(k) submission.

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