Product code NTO

Device name

Rinse, Oral, Antibacterial (By Physical Means)

Medical specialty

Dental

Device class

2

Regulation number

872.5580

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset