DERMADAM
Device Facts
| Record ID | K964810 |
|---|---|
| Device Name | DERMADAM |
| Applicant | Ultradent Products, Inc. |
| Product Code | EFS · Dental |
| Decision Date | Feb 10, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6510 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.
