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 |
| 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 |
| K230895 | CEFLA S.C. | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | 04/01/2024 |
| K213022 | CEFLA S.C. | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | 05/09/2022 |
| K231864 | Codent Technical Industry Co., Ltd. | Fiber Optic Brushless Electronic Micromotor, model: iM100 | 03/11/2024 |
| K083252 | DENTALEZ GROUP, STARDENTAL DIVISION | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM | 02/18/2009 |
| K193341 | Dentium Co., Ltd | iCTmotor (WL-1) | 09/04/2020 |
| K103653 | DENTSPLY INTERNATIONAL INC. | E3 TORQUE CONTROL MOTOR | 05/26/2011 |
| K161213 | DENTSPLY SIRONA | XSmart iQ | 02/10/2017 |
| K202075 | Foshan CICADA Dental Instrument Co, Ltd. | Dental Electric Motor | 03/11/2022 |
| K220831 | Foshan COXO Medical Instrument Co., Ltd. | Dental Implantation Systems, Dental Electrical Motors | 09/27/2022 |
| K242646 | Guilin AestheDent Medical Instruments Co., Ltd | Dental Implant Unit | 04/11/2025 |
| K203706 | Guilin Woodpecker Medical Instrument Co., Ltd. | Dental Electric Motor | 01/13/2022 |
| K211358 | Guilin Woodpecker Medical Instrument Co., Ltd. | Implanter incl. Accessories | 11/21/2022 |
| K180845 | Handpiece Headquarters - HPR Inc. | Maxima Electric System | 07/25/2019 |
| 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 | 08/15/2014 |
| K163317 | Kaltenbach & Voigt GmgH | ELECTROmatic | 02/21/2017 |
| K000120 | MICRO MOTORS, INC. | PRO-TORQ | 02/03/2000 |
| K231562 | Micro-NX Co., Ltd. | ELEC ENGINE (Model: ISE-170L) | 07/18/2025 |
| K201191 | MICRO-NX Co., Ltd. | ELEC-LED | 02/07/2022 |
| K201192 | MICRO-NX Co., Ltd. | Impla-NX (Model: ISE-270M) | 05/21/2021 |
| K233288 | Nakanishi Inc. | NLZ Built-In Motor System | 06/24/2024 |
| K163402 | NAKANISHI INC. | NLZ Motor System | 08/31/2017 |
| K173905 | Nakanishi Inc. | Surgic Pro, Surgic Pro+ | 06/19/2018 |
| K233117 | Nakanishi Inc. | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | 06/20/2024 |
| K163131 | NAKANISHI, INC. | A-dec NLZ Electric Motor System | 05/11/2017 |
| 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 |
| K201292 | Saeshin Precision Co., Ltd. | TRAUS SIP20 | 02/11/2021 |
| K092758 | SAESHIN PRECISION CO., LTD. | X-CUBE | 09/21/2009 |
| K141482 | SAEYANG MICROTECH CO LTD | KI-20 | 04/24/2015 |
| 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 |
| 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 |
| K181858 | W&H Dentalwerk Buermoos GmbH | Electric Handpiece Motor | 03/26/2019 |
| K041124 | W&H DENTALWERK BURMOOS | IRRIGATION TUBING SET 2.2M AND 3.8M | 06/07/2004 |
| K161957 | W&H DENTALWERK BURMOOS GMBH | W&H Implantmed SI-1015 incl. Accessories | 11/23/2016 |
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