FDA Product Code
FDA Product Code EKZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4920
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213477 | Root ZX3 | J. Morita USA, Inc. | 2022-08-03 | Traditional | PDF ↗ |
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Coltene/Whaledent, Inc. | 2007-10-18 | Abbreviated | PDF ↗ |
| K063468 | THE FUGO BLADE FOR DENTISTRY | Medisurg , Ltd. | 2007-04-18 | Traditional | PDF ↗ |
| K052622 | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT | Macan Engineering Co. | 2005-12-09 | Traditional | PDF ↗ |
| K050735 | MC6A | Macan Engineering Co. | 2005-05-23 | Traditional | PDF ↗ |
| K023672 | X O ODONTOSURGE 4 | Xo Care A/S | 2003-04-29 | Traditional | PDF ↗ |
| K020080 | BONART ART-E1 ELECTROSURGERY UNIT | Diagnostic Data, Inc. | 2002-02-19 | Traditional | PDF ↗ |
| K001560 | ODONTOSURGE 3 | Odonto-Wave | 2000-08-24 | Traditional | PDF ↗ |
| K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR | Wallach Surgical Devices, Inc. | 2000-04-11 | Traditional | PDF ↗ |
| K982229 | BI-DENT | Valley Forge Scientific Corp. | 1998-08-13 | Traditional | PDF ↗ |
| K981390 | ODONTOSURGE 2 | Periogiene | 1998-06-11 | Traditional | PDF ↗ |
| K962445 | ARTHROCARE DENTAL ELECTROSURGERY SYSTEM | Arthrocare Corp. | 1996-07-30 | Traditional | PDF ↗ |
| K955176 | DENTO-SURGE | Ellman Intl., Inc. | 1996-04-15 | Traditional | PDF ↗ |
| K950239 | SENSIMATIC 500SE | Parkell, Inc. | 1995-06-06 | Traditional | PDF ↗ |
| K925116 | ELECTROSURGICAL ELECTRODE | Premier | 1994-03-01 | Traditional | PDF ↗ |
| K921604 | TOUCH N' HEAT, MODIFICATION | Analytic Technology | 1992-08-24 | Traditional | PDF ↗ |
| K852522 | SATALEC SERVOTOME | Spelna, Inc. | 1985-12-27 | Traditional | PDF ↗ |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | Ipco Corp. | 1985-05-29 | Traditional | PDF ↗ |
| K830441 | DIFF 4 SYSTEM | Coulter Electronics, Inc. | 1983-05-16 | Traditional | PDF ↗ |
Product code EKZ · Class II · Dental. Data: openFDA.