DENTO-SURGE
Device Facts
| Record ID | K955176 |
|---|---|
| Device Name | DENTO-SURGE |
| Applicant | Ellman Intl., Inc. |
| Product Code | EKZ · Dental |
| Decision Date | Apr 15, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.
