510kDecisions.com

FDA 510(k) Applications for Medical Device Product Code "EBW"
(Controller, Foot, Handpiece And Cord)

FDA 510(k) Number Applicant Device Name Decision Date
K133776 A-DEC, INC. A-DEC/W&H ELECTRIC HANDPIECE MOTOR 05/28/2014
K032572 A-DEC, INC. A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT 12/03/2003
K102241 ANTHOGYR SAS ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT 03/23/2011
K790322 APPLIED MEDICAL RESEARCH OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 05/14/1979
K964860 BELL INTL., INC. MARK 20 AND MARK 25 HAND ENGINE CONTROLLER 03/03/1997
K964863 BELL INTL., INC. MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN 02/28/1997
K092214 BIEN-AIR DENTAL, SA CHIROPRO L SYSTEM 12/15/2009
K100785 BONART CO. LTD. BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES 12/03/2010
K770129 CHEMETRON HEALTH SYSTEMS SPRINT S-2 INSTRU. CENTER (MODEL 92329) 01/28/1977
K083252 DENTALEZ GROUP, STARDENTAL DIVISION NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM 02/18/2009
K103653 DENTSPLY INTERNATIONAL INC. E3 TORQUE CONTROL MOTOR 05/26/2011
K040153 INDIGENOUS PEOPLES TECHNOLOGY AND EDUCATION CENTER I-TEC PORTABLE DENTAL OPERATORY 05/21/2004
K090727 INNOVATIVE MEDICAL MANUFACTURING CO. IMM DENTAL IRRIGATION TUBING SET 08/13/2009
K992648 J. MORITA USA, INC. ROTARY MASTER 01/31/2000
K103027 KALTENBACH & VOIGT GMBH ELECTROTORQUE TLC 08/19/2011
K140308 KALTENBACH & VOIGT GMBH MASTERSURG / EXPERTSURG 8/15/2014
K000120 MICRO MOTORS, INC. PRO-TORQ 02/03/2000
K011926 NAKANISHI, INC. ELEC-MATE E 09/11/2001
K020327 NAKANISHI, INC. SURGIC IV IMPLANT CONTROL UNIT 04/08/2002
K990954 NSK NAKANISHI, INC. ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET 06/09/1999
K972924 NSK NAKANISHI, INC. SURGIC II IMPLANT CONTROL UNIT 10/30/1997
K092758 SAESHIN PRECISION CO., LTD. X-CUBE 09/21/2009
K123608 SAEYANG MICROTECH CO., LTD ENDO E CLASS 08/16/2013
K111623 SATELEC-ACTEON GROUP I-ENDO DUAL 01/10/2012
K090937 SCICAN LTD. E-STATIS 40 SYSTEM 07/24/2009
K031584 SIRONA DENTAL SYSTEMS GMBH SIROTORQUE L 08/19/2003
K905620 SITE MICROSURGICAL SYSTEMS, INC. MODIFIED SITE PERISTALTIC FOOTSWITCH 02/27/1991
K132570 TTBIO CORP. ELECTRIC HANDPIECE SYSTEM 04/29/2014
K972889 W & H DENTALWERK ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) 01/22/1998
K060287 W & H DENTALWERK BUERMOOS GMBH DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM 05/03/2006
K014068 W & H DENTALWERK BUERMOOS GMBH ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 05/03/2002
K052741 W & H DENTALWERK BUERMOOS GMBH IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES 01/13/2006
K002469 W & H DENTALWERK BUERMOOS GMBH IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) 02/07/2001
K041124 W&H DENTALWERK BURMOOS IRRIGATION TUBING SET 2.2M AND 3.8M 06/07/2004


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