NTO

Rinse, Oral, Antibacterial (By Physical Means)

Product code

NTO

Device name

Rinse, Oral, Antibacterial (By Physical Means)

Device class

Class 2

21 CFR

21 CFR 872.5580

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).