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..
62
Total
62
Cleared
213d
Avg days
1977
Since
62 devices
Cleared
Feb 21, 2017
ELECTROmatic
Kaltenbach & Voigt Gmgh
Dental
90d
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
Aug 19, 2011
ELECTROTORQUE TLC
Kaltenbach & Voigt GmbH
Dental
310d
Cleared
May 26, 2011
E3 TORQUE CONTROL MOTOR
Dentsply International, Inc.
Dental
164d
Cleared
Mar 23, 2011
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
Anthogyr Sas
Dental
226d
Cleared
Dec 03, 2010
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
Bonart Co., Ltd.
Dental
259d
Cleared
Dec 15, 2009
CHIROPRO L SYSTEM
Bien-Air Dental, SA
Dental
146d
Cleared
Sep 21, 2009
X-CUBE
Saeshin Precision Co., Ltd.
Dental
12d
Cleared
Aug 13, 2009
IMM DENTAL IRRIGATION TUBING SET
Innovative Medical Manufacturing Co.
Dental
147d
Cleared
Jul 24, 2009
E-STATIS 40 SYSTEM
Scican , Ltd.
Dental
112d
Cleared
Feb 18, 2009
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
Dentalez Group, Stardental Division
Dental
106d
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
May 21, 2004
I-TEC PORTABLE DENTAL OPERATORY
Indigenous Peoples Technology and Education Center
Dental
119d
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