DECAPINOL ORAL RINSE
Device Facts
| Record ID | DEN050001 |
|---|---|
| Device Name | DECAPINOL ORAL RINSE |
| Applicant | Sinclair Pharmaceuticals Limited |
| Product Code | NTO · Dental |
| Decision Date | Apr 18, 2005 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 872.5580 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The device is assigned the generic name oral rinse to reduce the adhesion of dental plaque and is identified as a device intended to reduce the presence of bacterial plaque on teeth and oral mucosal surfaces by physical means. The device type includes those devices that act by reducing the attachment and inhibiting the growth of bacterial plaque.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental Plaque.” See § 872.1(e) for the availability of this guidance document.
