K955176 is an FDA 510(k) clearance for the DENTO-SURGE. This device is classified as a Unit, Electrosurgical, And Accessories, Dental (Class II - Special Controls, product code EKZ).
Submitted by Ellman Intl., Inc. (Sound Beach, US). The FDA issued a Cleared decision on April 15, 1996, 154 days after receiving the submission on November 13, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4920.
| 510(k) Number | K955176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1995 |
| Decision Date | April 15, 1996 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EKZ — Unit, Electrosurgical, And Accessories, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4920 |