NTO — Rinse, Oral, Antibacterial (By Physical Means) Class II
FDA product code NTO covers "Rinse, Oral, Antibacterial (By Physical Means)", a Class II medical device regulated under 21 CFR 872.5580. Submissions are reviewed by the Dental panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NTO
- Device Class
- Class II
- Regulation Number
- 872.5580
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
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.