EKZ · Unit, Electrosurgical, And Accessories, Dental
Dental · 21 CFR 872.4920 · Class 2
Overview
| Product Code | EKZ |
|---|---|
| Device Name | Unit, Electrosurgical, And Accessories, Dental |
| Regulation | 21 CFR 872.4920 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213477 | Root ZX3 | J. Morita USA, Inc. | Aug 3, 2022 | SESE |
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Coltene/Whaledent, Inc. | Oct 18, 2007 | SESE |
| K063468 | THE FUGO BLADE FOR DENTISTRY | Medisurg , Ltd. | Apr 18, 2007 | SESE |
| K052622 | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT | Macan Engineering Co. | Dec 9, 2005 | SESE |
| K050735 | MC6A | Macan Engineering Co. | May 23, 2005 | SESE |
| K023672 | X O ODONTOSURGE 4 | Xo Care A/S | Apr 29, 2003 | SESE |
| K020080 | BONART ART-E1 ELECTROSURGERY UNIT | Diagnostic Data, Inc. | Feb 19, 2002 | SESE |
| K001560 | ODONTOSURGE 3 | Odonto-Wave | Aug 24, 2000 | SESE |
| K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Wallach Surgical Devices, Inc. | Apr 11, 2000 | SESE |
| K982229 | BI-DENT | Valley Forge Scientific Corp. | Aug 13, 1998 | SESE |
| K981390 | ODONTOSURGE 2 | Periogiene | Jun 11, 1998 | SESE |
| K962445 | ARTHROCARE DENTAL ELECTROSURGERY SYSTEM | Arthrocare Corp. | Jul 30, 1996 | SESE |
| K955176 | DENTO-SURGE | Ellman Intl., Inc. | Apr 15, 1996 | SESE |
| K950239 | SENSIMATIC 500SE | Parkell, Inc. | Jun 6, 1995 | SESE |
| K925116 | ELECTROSURGICAL ELECTRODE | Premier | Mar 1, 1994 | SESE |
| K921604 | TOUCH N' HEAT, MODIFICATION | Analytic Technology | Aug 24, 1992 | SESE |
| K852522 | SATALEC SERVOTOME | Spelna, Inc. | Dec 27, 1985 | SESE |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | Ipco Corp. | May 29, 1985 | SESE |
| K830441 | DIFF 4 SYSTEM | Coulter Electronics, Inc. | May 16, 1983 | SESE |
Top Applicants
- Macan Engineering Co. — 2 clearances
- Xo Care A/S — 1 clearance
- Wallach Surgical Devices, Inc. — 1 clearance
- Valley Forge Scientific Corp. — 1 clearance
- Spelna, Inc. — 1 clearance
