FDA Product Code EBW: Controller, Foot, Handpiece And Cord
FDA product code EBW covers foot controllers, dental handpiece bodies, and cords used as accessories in dental procedures.
These components enable hands-free speed control of dental handpieces through foot pedal activation, allowing the clinician to adjust rotational speed without removing hands from the operative field. They are used with air-driven and electric dental handpiece systems.
EBW devices are Class I medical devices, regulated under 21 CFR 872.4200 and reviewed by the FDA Dental panel.
Leading manufacturers include Nakanishi, Inc., W&H Dentalwerk Buermoos GmbH and Micro-Nx Co., Ltd..
61
Total
61
Cleared
212d
Avg days
1977
Since
61 devices
Cleared
Feb 10, 2017
XSmart iQ
Dentsply Sirona
Dental
287d
Cleared
Nov 23, 2016
W&H Implantmed SI-1015 incl. Accessories
W&H Dentalwerk Burmoos GmbH
Dental
128d
Cleared
Apr 24, 2015
KI-20
Saeyang Microtech Co., Ltd.
Dental
324d
Cleared
Aug 15, 2014
MASTERSURG / EXPERTSURG
Kaltenbach & Voigt GmbH
Dental
189d
Cleared
May 28, 2014
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
A-Dec, Inc.
Dental
167d
Cleared
Apr 29, 2014
ELECTRIC HANDPIECE SYSTEM
Ttbio Corp.
Dental
257d
Cleared
Aug 16, 2013
ENDO E CLASS
Saeyang Microtech Co., Ltd.
Dental
268d
Cleared
Jan 10, 2012
I-ENDO DUAL
Satelec - Acteon Group
Dental
214d
Cleared
May 26, 2011
E3 TORQUE CONTROL MOTOR
Dentsply International, Inc.
Dental
164d
Cleared
Sep 21, 2009
X-CUBE
Saeshin Precision Co., Ltd.
Dental
12d
Cleared
May 03, 2006
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
W&H Dentalwerk Buermoos GmbH
Dental
86d
Cleared
Jan 13, 2006
IMPLANTMED SI-915 (115V VERSION)
W&H Dentalwerk Buermoos GmbH
Dental
105d
Cleared
Jun 07, 2004
IRRIGATION TUBING SET 2.2M AND 3.8M
W&H Dentalwerk Burmoos
Dental
39d
Cleared
Dec 03, 2003
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
A-Dec, Inc.
Dental
105d
Cleared
Aug 19, 2003
SIROTORQUE L
Sirona Dental Systems GmbH
Dental
90d
Cleared
May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
W&H Dentalwerk Buermoos GmbH
Dental
144d
Cleared
Apr 08, 2002
SURGIC IV IMPLANT CONTROL UNIT
Nakanishi, Inc.
Dental
67d
Cleared
Sep 11, 2001
ELEC-MATE E
Nakanishi, Inc.
Dental
83d
Cleared
Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
W&H Dentalwerk Buermoos GmbH
Dental
180d
Cleared
Jan 31, 2000
ROTARY MASTER
J. Morita USA, Inc.
Dental
178d
Cleared
Jun 09, 1999
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
Nsk Nakanishi, Inc.
Dental
79d
Cleared
Jan 22, 1998
ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION)
W & H Dentalwerk
Dental
170d
Cleared
Oct 30, 1997
SURGIC II IMPLANT CONTROL UNIT
Nsk Nakanishi, Inc.
Dental
83d
Cleared
Mar 03, 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
Bell Intl., Inc.
Dental
89d