510(k) K020080
- Device
- BONART ART-E1 ELECTROSURGERY UNIT
- Applicant
- DIAGNOSTIC DATA, INC.
- 510(k) number
- K020080
- Product code
- EKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-02-19
- Date received
- 2002-01-09
- Regulation
- 872.4920
- Classification name
- Unit, Electrosurgical, And Accessories, Dental
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT E JOHNSON
- Address
- 1342-D N. Benson Ave. Upland CA US 91786 91786
FDA Registration Numbers#
- 1222993
- 3038718579
- 8044015
- 3009905888
- 1418975
- 2416455
- 9710363
- 3002807636
- 2411797
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EKZ #
| 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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases