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VOCO Profluorid L is intended for use as

• treatment of hypersensitive teeth,
• sealing the dentinal tubules for cavity preparations or on sensitive root surfaces cavity liner under amalgam restorations

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This document is a 510(k) premarket notification decision letter from the FDA for a dental product called "VOCO Profluorid L". It primarily focuses on regulatory approval and does not contain details about acceptance criteria, study designs, or performance metrics for a device in the way a clinical study report or a technical performance document would.

Therefore, I cannot extract the requested information about acceptance criteria and study details from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market approval. However, it does not provide the specific performance data or study methodology that would typically be contained within a device's submission to demonstrate that equivalence.

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