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..

61
Total
61
Cleared
212d
Avg days
1977
Since
61 devices
25–48 of 61
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 May 26, 2011
E3 TORQUE CONTROL MOTOR
K103653
Dentsply International, Inc.
Dental · 164d
Cleared Sep 21, 2009
X-CUBE
K092758
Saeshin Precision Co., Ltd.
Dental · 12d
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 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
Cleared May 03, 2002
ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115
K014068
W&H Dentalwerk Buermoos GmbH
Dental · 144d
Cleared Apr 08, 2002
SURGIC IV IMPLANT CONTROL UNIT
K020327
Nakanishi, Inc.
Dental · 67d
Cleared Sep 11, 2001
ELEC-MATE E
K011926
Nakanishi, Inc.
Dental · 83d
Cleared Feb 07, 2001
IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)
K002469
W&H Dentalwerk Buermoos GmbH
Dental · 180d
Cleared Jan 31, 2000
ROTARY MASTER
K992648
J. Morita USA, Inc.
Dental · 178d
Cleared Jun 09, 1999
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
K990954
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)
K972889
W & H Dentalwerk
Dental · 170d
Cleared Oct 30, 1997
SURGIC II IMPLANT CONTROL UNIT
K972924
Nsk Nakanishi, Inc.
Dental · 83d
Cleared Mar 03, 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860
Bell Intl., Inc.
Dental · 89d