K964810 is an FDA 510(k) clearance for the DERMADAM. This device is classified as a Unit, Oral Irrigation (Class I - General Controls, product code EFS).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 10, 1997, 73 days after receiving the submission on November 29, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6510.
| 510(k) Number | K964810 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 1996 |
| Decision Date | February 10, 1997 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EFS — Unit, Oral Irrigation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6510 |