Definition: Intended As A Physical Barrier For Temporary Protection Of Oral Mucosal Tissue And To Provide Pain Relief. Unclassified Status Per SE To MGQ.
| Device Type ID | 1422 |
| Device Name | Oral Wound Dressing |
| Physical State | A Viscous Liquid Or Gel |
| Technical Method | Supplied As An Oral Rinse Or As A Gel, Liquid Or Patch To Be Directly Applied To An Oral Wound |
| Target Area | Oral Mucosal Tissue |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | OLR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1422 |
| Device | Oral Wound Dressing |
| Product Code | OLR |