Unit, Electrosurgical, And Accessories, Dental
Regulation 872.4920
0510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in EKZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Macan Engineering Co. | 2 | 0 |
| Analytic Technology | 1 | 0 |
| Arthrocare Corp. | 1 | 0 |
| Coltene/Whaledent, Inc. | 1 | 0 |
| Coulter Electronics, Inc. | 1 | 0 |
| Diagnostic Data, Inc. | 1 | 0 |
| Ellman Intl., Inc. | 1 | 0 |
| Ipco Corp. | 1 | 0 |
| J. Morita USA, Inc. | 1 | 0 |
| Macan Engineering and Manufacturing Co., Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2022 | K213477 | Root ZX3 J. Morita USA, Inc. | EKZ |
| Oct 18, 2007 | K071632 | PERFECT TISSUE CONTOURING SYSTEM II Coltene/Whaledent, Inc. | EKZ |
| Apr 18, 2007 | K063468 | THE FUGO BLADE FOR DENTISTRY Medisurg , Ltd. | EKZ |
| Dec 9, 2005 | K052622 | MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT Macan Engineering Co. | EKZ |
| May 23, 2005 | K050735 | MC6A Macan Engineering Co. | EKZ |
| Apr 29, 2003 | K023672 | X O ODONTOSURGE 4 Xo Care A/S | EKZ |
| Feb 19, 2002 | K020080 | BONART ART-E1 ELECTROSURGERY UNIT Diagnostic Data, Inc. | EKZ |
| Aug 24, 2000 | K001560 | ODONTOSURGE 3 Odonto-Wave | EKZ |
| Apr 11, 2000 | K000768 | WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR Wallach Surgical Devices, Inc. | EKZ |
| Aug 13, 1998 | K982229 | BI-DENT Valley Forge Scientific Corp. | EKZ |
| Jun 11, 1998 | K981390 | ODONTOSURGE 2 Periogiene | EKZ |
| Jul 30, 1996 | K962445 | ARTHROCARE DENTAL ELECTROSURGERY SYSTEM Arthrocare Corp. | EKZ |
| Apr 15, 1996 | K955176 | DENTO-SURGE Ellman Intl., Inc. | EKZ |
| Jun 6, 1995 | K950239 | SENSIMATIC 500SE Parkell, Inc. | EKZ |
| Mar 1, 1994 | K925116 | ELECTROSURGICAL ELECTRODE Premier | EKZ |
| Aug 24, 1992 | K921604 | TOUCH N' HEAT, MODIFICATION Analytic Technology | EKZ |
| Dec 27, 1985 | K852522 | SATALEC SERVOTOME Spelna, Inc. | EKZ |
| May 29, 1985 | K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT Ipco Corp. | EKZ |
| May 16, 1983 | K830441 | DIFF 4 SYSTEM Coulter Electronics, Inc. | EKZ |
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