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For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.

The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.

This document focuses on the substantial equivalence of the Sci-Pharm DFV Varnish to legally marketed predicate devices, rather than establishing acceptance criteria or performance through a clinical study with numerical metrics like sensitivity, specificity, or accuracy.

The manufacturer, Scientific Pharmaceuticals, Inc., sought 510(k) clearance from the FDA for their Sci-Pharm DFV Varnish. The clearance relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific, pre-defined acceptance criteria through a clinical performance study.

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1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not directly applicable here because the submission is based on substantial equivalence, not a performance study against specific acceptance criteria. Instead, the document compares the chemical composition and device function to predicate devices.

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