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Sinclair Pharma's Gum Disease Mouthwash Gains 510(k) Clearance

This article was originally published in The Pink Sheet Daily

Executive Summary

The company has not yet identified a marketing partner for the prescription-use oral rinse Decapinol. The product was vetted by FDA's Office of Combination Products and is considered a device because "its primary mode of action is to create a physical barrier," preventing bacteria from clinging to tooth surfaces, agency says.

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