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• Treatment of dentinal hypersensitivity
• Treatment of exposed cervicals
• Treatment of sensitivity after tooth whitening

Fluor Protector S is a desensitizing agent used for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparation. The primary difference between the subject device and the predicate device is the use of Ammonium fluoride in the subject device. Even though there is an approximately 8-fold difference in fluoride content in solution between the subject device and the predicate device, the difference is only 3.6-fold in the dry varnish, which is the "active state" of the device. Apart from fluoride content, the varnishes are very similar (low viscosity, clear, transparent, multi- and single dose).

This document is a 510(k) summary for a dental product called "Fluor Protector S" and does not contain the information requested in the prompt about acceptance criteria and a study proving a device meets them. The document is primarily focused on demonstrating substantial equivalence to a predicate device, as required for FDA clearance.

Therefore, I cannot extract the requested information from the provided text.

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