DeviceClearance

Product code NTO— Dental

DECAPINOL ORAL RINSE

Classification name
Rinse, Oral, Antibacterial (By Physical Means)
Device class
Class 2
Regulation
21 CFR 872.5580
Advisory panel
Dental
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NTO under 21 CFR 872.5580, via openFDA

Market context for product code NTO

FDA has cleared 2 devices under product code NTO between 2005 and 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NTO

Recent clearances under product code NTO

Data sourced from openFDA. This site is unofficial and independent of the FDA.