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• Treatment of hypersensitive teeth.

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This document is a 510(k) premarket notification letter from the FDA regarding "Alpha-Pro White Varnish." It is not a study or regulatory document that contains the detailed information requested.

Therefore, I cannot provide the acceptance criteria and study details you've asked for based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data, detailed study designs, or acceptance criteria.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed submission document that describes the studies conducted for this device.

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• Core buildups. ■
• . Cementation of pins and posts when used with suitable dentin adhesive.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "Alpha-Core DC" device, primarily focused on confirming its substantial equivalence to a predicate device for specific indications of use (core buildups and cementation of pins and posts).

The letter does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about a study's sample size, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) studies, effect sizes, or standalone algorithm performance.
• Details on the sample size or ground truth establishment for a training set (which would be relevant for AI/ML devices, but this device is a dental material).

Therefore, I cannot fulfill your request based on the provided input.

Ask a specific question about this device