Product code EKZ
- Device name
- Unit, Electrosurgical, And Accessories, Dental
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4920
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K213477 | Root ZX3 | J. Morita USA, Inc. | 2022-08-03 |
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Coltene/Whaledent, Inc. | 2007-10-18 |
| K063468 | THE FUGO BLADE FOR DENTISTRY | Medisurg , Ltd. | 2007-04-18 |
| K052622 | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT | Macan Engineering Co. | 2005-12-09 |
| K050735 | MC6A | Macan Engineering Co. | 2005-05-23 |
| K023672 | X O ODONTOSURGE 4 | Xo Care A/S | 2003-04-29 |
| K020080 | BONART ART-E1 ELECTROSURGERY UNIT | Diagnostic Data, Inc. | 2002-02-19 |
| K001560 | ODONTOSURGE 3 | Odonto-Wave | 2000-08-24 |
| K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Wallach Surgical Devices, Inc. | 2000-04-11 |
| K982229 | BI-DENT | Valley Forge Scientific Corp. | 1998-08-13 |
| K981390 | ODONTOSURGE 2 | Periogiene | 1998-06-11 |
| K962445 | ARTHROCARE DENTAL ELECTROSURGERY SYSTEM | Arthrocare Corp. | 1996-07-30 |
| K955176 | DENTO-SURGE | Ellman Intl., Inc. | 1996-04-15 |
| K950239 | SENSIMATIC 500SE | Parkell, Inc. | 1995-06-06 |
| K925116 | ELECTROSURGICAL ELECTRODE | Premier | 1994-03-01 |
| K921604 | TOUCH N' HEAT, MODIFICATION | Analytic Technology | 1992-08-24 |
| K852522 | SATALEC SERVOTOME | Spelna, Inc. | 1985-12-27 |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | Ipco Corp. | 1985-05-29 |
| K830441 | DIFF 4 SYSTEM | Coulter Electronics, Inc. | 1983-05-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04548213056545 | Root ZX3 | J.MORITA MFG.CORP. | 2023-06-27 |
| 00810000520701 | Sensimatic™ | PARKELL, INC. | 2018-09-14 |
| 00810000526710 | Parkell® | PARKELL, INC. | 2018-09-14 |
| 00810000526727 | Parkell® | PARKELL, INC. | 2018-09-14 |
| 00810000526734 | Parkell® | PARKELL, INC. | 2018-09-14 |
| 00810000526741 | Parkell® | PARKELL, INC. | 2018-09-14 |
| 00810000526758 | Parkell® | PARKELL, INC. | 2018-09-14 |
| 00810000526765 | Parkell® | PARKELL, INC. | 2018-09-14 |
| M595S397AP150 | NA | PARKELL, INC. | 2016-09-23 |
| M595D700SE10CR0 | Sensimatic™ | PARKELL, INC. | 2016-09-23 |
| M595D600SE1100 | Sensimatic™ | PARKELL, INC. | 2016-09-23 |
| D661S6015A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S2130 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6000A1 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S8FSRK0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S81150 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S7010A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S70010 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6018A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6017A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6016A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6005A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6014A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6013A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6012A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6011A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6010A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6008CE0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6008A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |
| D661S6007A0 | PerFect TCS | COLTENE/WHALEDENT INC | 2016-06-16 |