NTO · Rinse, Oral, Antibacterial (By Physical Means)
Dental · 21 CFR 872.5580 · Class 2
Overview
| Product Code | NTO |
|---|---|
| Device Name | Rinse, Oral, Antibacterial (By Physical Means) |
| Regulation | 21 CFR 872.5580 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K053166 | SINCLAIR ORAL RINSE | Sinclair Pharmaceuticals Limited | May 17, 2006 | SESE |
| DEN050001 | DECAPINOL ORAL RINSE | Sinclair Pharmaceuticals Limited | Apr 18, 2005 | DENG |
Top Applicants
- Sinclair Pharmaceuticals Limited — 2 clearances
