EBW · Class I · 21 CFR 872.4200

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
25–48 of 62
Cleared Feb 21, 2017
ELECTROmatic
K163317
Kaltenbach & Voigt Gmgh
Dental · 90d
Cleared Feb 10, 2017
XSmart iQ
K161213
Dentsply Sirona
Dental · 287d
Cleared Nov 23, 2016
W&H Implantmed SI-1015 incl. Accessories
K161957
W&H Dentalwerk Burmoos GmbH
Dental · 128d
Cleared Apr 24, 2015
KI-20
K141482
Saeyang Microtech Co., Ltd.
Dental · 324d
Cleared Aug 15, 2014
MASTERSURG / EXPERTSURG
K140308
Kaltenbach & Voigt GmbH
Dental · 189d
Cleared May 28, 2014
A-DEC/W&H ELECTRIC HANDPIECE MOTOR
K133776
A-Dec, Inc.
Dental · 167d
Cleared Apr 29, 2014
ELECTRIC HANDPIECE SYSTEM
K132570
Ttbio Corp.
Dental · 257d
Cleared Aug 16, 2013
ENDO E CLASS
K123608
Saeyang Microtech Co., Ltd.
Dental · 268d
Cleared Jan 10, 2012
I-ENDO DUAL
K111623
Satelec - Acteon Group
Dental · 214d
Cleared Aug 19, 2011
ELECTROTORQUE TLC
K103027
Kaltenbach & Voigt GmbH
Dental · 310d
Cleared May 26, 2011
E3 TORQUE CONTROL MOTOR
K103653
Dentsply International, Inc.
Dental · 164d
Cleared Mar 23, 2011
ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
K102241
Anthogyr Sas
Dental · 226d
Cleared Dec 03, 2010
BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES
K100785
Bonart Co., Ltd.
Dental · 259d
Cleared Dec 15, 2009
CHIROPRO L SYSTEM
K092214
Bien-Air Dental, SA
Dental · 146d
Cleared Sep 21, 2009
X-CUBE
K092758
Saeshin Precision Co., Ltd.
Dental · 12d
Cleared Aug 13, 2009
IMM DENTAL IRRIGATION TUBING SET
K090727
Innovative Medical Manufacturing Co.
Dental · 147d
Cleared Jul 24, 2009
E-STATIS 40 SYSTEM
K090937
Scican , Ltd.
Dental · 112d
Cleared Feb 18, 2009
NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM
K083252
Dentalez Group, Stardental Division
Dental · 106d
Cleared May 03, 2006
DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
K060287
W&H Dentalwerk Buermoos GmbH
Dental · 86d
Cleared Jan 13, 2006
IMPLANTMED SI-915 (115V VERSION)
K052741
W&H Dentalwerk Buermoos GmbH
Dental · 105d
Cleared Jun 07, 2004
IRRIGATION TUBING SET 2.2M AND 3.8M
K041124
W&H Dentalwerk Burmoos
Dental · 39d
Cleared May 21, 2004
I-TEC PORTABLE DENTAL OPERATORY
K040153
Indigenous Peoples Technology and Education Center
Dental · 119d
Cleared Dec 03, 2003
A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT
K032572
A-Dec, Inc.
Dental · 105d
Cleared Aug 19, 2003
SIROTORQUE L
K031584
Sirona Dental Systems GmbH
Dental · 90d