Therapeutic devices · 21 CFR 872 Subpart F
Antibacterial (by Physical Means) Oral Rinse
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.
- Companies listing it
- 11 makers
- Brands and models
- 1
- 510(k) clearances
- 20 in five years
- FDA name
- Rinse, Oral, Antibacterial (By Physical Means)
510(k) clearances per year, 1976–2026
Companies that list NTO
1 company currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sigmar Italia S.p.A. | Italy | Maker | Decapinol Oral Rinse | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 17 May 2006 | K053166 | SINCLAIR ORAL RINSE | Sinclair Pharmaceuticals Limited |
| 18 Apr 2005 | DEN050001 | DECAPINOL ORAL RINSE | Sinclair Pharmaceuticals Limited |
Official records: FDA product classification for NTO · 21 CFR 872.5580.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026