Controller, Foot, Handpiece And Cord
Regulation 872.4200
3510(k)s in 12 months (62 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in EBW
| Company | 510(k)s | Recalls |
|---|---|---|
| Nakanishi, Inc. | 7 | 0 |
| W&H Dentalwerk Buermoos GmbH | 5 | 0 |
| Micro-Nx Co., Ltd. | 3 | 0 |
| Saeshin Precision Co., Ltd. | 3 | 0 |
| A-Dec, Inc. | 2 | 0 |
| Bell Intl., Inc. | 2 | 0 |
| Cefla S.C. | 2 | 0 |
| Dentsply Sirona | 2 | 0 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | 2 | 0 |
| Kaltenbach & Voigt GmbH | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2001 | K011926 | ELEC-MATE E Nakanishi, Inc., JP | EBW |
| Feb 7, 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) W&H Dentalwerk Buermoos GmbH, AT | EBW |
| Feb 3, 2000 | K000120 | PRO-TORQ Micro Motors, Inc. | EBW |
| Jan 31, 2000 | K992648 | ROTARY MASTER J. Morita USA, Inc. | EBW |
| Jun 9, 1999 | K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET Nsk Nakanishi, Inc., JP | EBW |
| Jan 22, 1998 | K972889 | ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) W & H Dentalwerk, AT | EBW |
| Oct 30, 1997 | K972924 | SURGIC II IMPLANT CONTROL UNIT Nsk Nakanishi, Inc., JP | EBW |
| Mar 3, 1997 | K964860 | MARK 20 AND MARK 25 HAND ENGINE CONTROLLER Bell Intl., Inc. | EBW |
| Feb 28, 1997 | K964863 | MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN Bell Intl., Inc. | EBW |
| Feb 27, 1991 | K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH Site Microsurgical Systems, Inc. | EBW |
| May 14, 1979 | K790322 | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 Applied Medical Research | EBW |
| Jan 28, 1977 | K770129 | SPRINT S-2 INSTRU. CENTER (MODEL 92329) Chemetron Health Systems | EBW |
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