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.
| Device Type ID | 1357 |
| Device Name | Rinse, Oral, Antibacterial (by Physical Means) |
| Regulation Description | Oral Rinse To Reduce The Adhesion Of Dental Plaque. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NTO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1357 |
| Device | Rinse, Oral, Antibacterial (by Physical Means) |
| Product Code | NTO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Oral Rinse To Reduce The Adhesion Of Dental Plaque. |
| CFR Regulation Number | 872.5580 [🔎] |