Fluoride gel

Fluoride gel is a topical dental preparation formulated as a gel that contains fluorine in a chemically active form and at a concentration sufficient to treat tooth surfaces. It is applied directly to the teeth to support enamel health and is intended for single use only, meaning it is discarded after application.

Devices in this category are regulated as medical devices based on their mechanism of action and intended use, typically falling under classifications that govern topical dental treatments. They are supplied as single-use applicators or pre-measured doses and are not intended to be reused, reprocessed, or refilled after application.