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The General Purpose Dental Tray is a single patient, single use, disposable device which is intended to conveniently provide general use auxiliary components for the administration of dental procedures.

The General Purpose Dental Tray is intended to conveniently provide the auxiliary components utilized during general dental procedures. The components are items that are commonly used during a variety of dental procedures. The general Purpose Dental Tray provides the convenience of having these commonly used items packaged in a single package, sterile, and ready to use. The kits are provided sterile, disposable, and for single patient use.

This document is a 510(k) summary for a General Purpose Dental Tray. It describes the device, its intended use, and its technological characteristics in comparison to a predicate device.

The provided text does not contain any information about acceptance criteria, device performance metrics, or study details such as sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the input provided. The document focuses on regulatory submission information rather than performance evaluation.

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