The following data is part of a De Novo classification by Sinclair Pharmaceuticals Limited with the FDA for Decapinol Oral Rinse.
| DeNovo ID | DEN050001 |
| Device Name: | DECAPINOL ORAL RINSE |
| Classification | Rinse, Oral, Antibacterial (by Physical Means) |
| Applicant | SINCLAIR PHARMACEUTICALS LIMITED borough Road Godalming, GB |
| Contact | Michael Killeen |
| Product Code | NTO |
| CFR Regulation Number | 872.5580 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K041482 |
| Review Advisory Board | Dental |
| Classification Advisory | Dental |
| Type | Post-NSE |
| Date Received | 2005-01-24 |
| Decision Date | 2005-04-18 |
| Reclassification Order: | Reclassification Order |