510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NTOClass II

Rinse, Oral, Antibacterial (By Physical Means)

21 CFR 872.5580 / Dental
FDA source (opens on fda.gov)

NTO is the FDA product code for Rinse, Oral, Antibacterial (By Physical Means), a class II device type, regulated under 21 CFR 872.5580. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
NTO
Device name
Rinse, Oral, Antibacterial (By Physical Means)
FDA 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.
Regulation
21 CFR 872.5580
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
2

Clearances, product code NTO

By decision year
2 clearances under product code NTO with a decision year between 2005 and 2006, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NTO by decision year
YearClearances
20051
20061

Applicants with the most clearances

Product code NTO
Applicants holding the most 510(k) clearances under product code NTO
ApplicantClearances
Sinclair Pharmaceuticals Ltd2

Companies listing this code with FDA

Companies whose registered establishments list this code