NTO

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Rinse, Oral, Antibacterial (By Physical Means)

Device class

Class II (moderate risk)

Regulation

21 CFR 872.5580

Medical specialty

Dental

Flags

Third-party review eligible

FDA definition

Antibacterial oral rinse that is used as an aid in the treatment of gingivitis, acting by physical rather than chemical means. The rinse works by coating tooth and tissue surfaces, providing a positive charge that reduces bacterial adhesion.

Adverse events (MAUDE)

2021: 23
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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