FDA product code NTO

Rinse, Oral, Antibacterial (By Physical Means)

Dental·Class 2·21 CFR 872.5580
US regulatory classifications
US Product Code (FDA)
NTO
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 872.5580
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Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Rinse, Oral, Antibacterial (By Physical Means) is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.