Surgical devices · 21 CFR 872 Subpart E
Handpiece and Cord Foot Controller
FDA device type “Controller, Foot, Handpiece And Cord”.
- Companies listing it
- 5330 makers
- Brands and models
- 365
- 510(k) clearances
- 6216 in five years
- FDA name
- Controller, Foot, Handpiece And Cord
510(k) clearances per year, 1976–2026
Companies that list EBW
53 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | IMPLANTEO · IMPLANTEO LED | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Nakanishi, Inc. | Japan | Maker | EL400JS120 · EL400S120 · ELEC-MATE · ELM40M · +80 | 37 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TL · Contra-angle handpiece: WJ-45L · Contra-angle handpiece: WP-1, WP-1L, WJ-11L · Dental Electric Motor · +3 | 12 | 2025 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Dental Electrical Motors; C-PUMA MASTER · Dental Implantation Systems; C-Sailor Pro | 6 | 2025 |
| Cefla S.C. | Italy | Maker | handy POWER · handy POWER LED · handy POWER LED FLUO · i-MMr · +11 | 15 | 2026 |
| MICRO-NX Co., Ltd. | South Korea | Maker | Choice Pro · ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170) · ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170C) · ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170L) · +8 | 7 | 2025 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | AHP-85-SS · DENTIS DIP20 · Harpoon 1 · Motor Handpiece and Control Unit (SDI10) · +4 | 16 | 2026 |
| Satelec - Acteon Group | United States | Maker | Dental Hand-Piece and Accessories · ENDO Dual · EVOS · i-endo dual dental motor, endo motion | 18 | 2024 |
| Dentalez, Inc. | United States | Maker | Star E900 Electric System · Star ETorque Electric Motor System - 265461, 265464, 265463, 268880 | 9 | 2026 |
| Handpiece Headquarters | United States | Maker | ChoicePro · Medilectric · Thor 700+ | 7 | 2024 |
| A-dec, Inc. | United States | Maker | A-dec XC10 Electric Motor · EA-30 · EA-40LT · EA-50LT · +9 | 68 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Codent Technical Industry Co., Ltd. | Taiwan | Maker | Fiber Optic Brushless Electronic Micromotor (iM100) | 5 | 2024 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Dental Electric Motor: NL 400-1,NL 400-2,NL 400-3, NL 400-4 | 4 | 2022 |
| Dentium Co.,Ltd(ICT branch) | South Korea | Maker | iCTmotor | 3 | 2023 |
| KaVo Dental GmbH | Germany | Maker | COMFORTdrive 200 XD - 100.5500 · ELECTROmatic C - L - 112.8540 · ELECTROmatic C - S - 112.8539 · ELECTROmatic M - L - 112.8538 · +45 | 2 | 2021 |
| Olsen Indústria E Comércio S.A. | Brazil | Maker | Controller, foot, handpiece and cordUnit, operative dental · Unit, operative dental | 2 | 2022 |
| Guilin AestheDent Medical Instruments Co., Ltd | China | Maker | Dental Implant Unit; IMPLANT surg, IMPLANT Classical | 1 | 2025 |
| Bonart Co., Ltd. | Taiwan | Maker | ART-IM1 IMPLANTOR SYSTEM AND ACCESSORIES | 14 | 2017 |
| Bien-Air Dental, SA | Switzerland | Maker | AQUACARE · CA 20:1 · CA 20:1 L · CA 20:1 l MICRO SERIES · +62 | 1 | 2009 |
| Onvet Medical Canada Inc. | Canada | Maker | iTesla Dental Implant System | — | — |
| Sanko Electronics Corporation | Japan | Maker | EL400JS120 · EL400S120 · FC-78 · NE136 · +17 | — | — |
| SycoTec GmbH & Co KG | Germany | Maker | A-dec XC10 Electric Motor · E-SANAO Advantage · E-SANAO Prep · E-STATIS Advantage · +4 | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Dental Implant Unit | — | — |
| Millstone Medical Outsourcing LLC | United States | Maker | CONTROLLER, FOOT, HANDPIECE AND CORD | — | — |
| Tani Electronics Corporation | Japan | Maker | FC-78 · Surgic Pro NON-OPT(120V) · Surgic Pro OPT(120V) · Surgic Pro OPT(230V) · +1 | — | — |
| SAEYANG Co.,Ltd 韩国（株）世洋 | South Korea | Maker | Endo E Class · Ki-20 | — | — |
| ARTHREX Inc. | United States | Maker | AR-200 - Clips | — | — |
| Force Engineering Co.ltd | Japan | Maker | FC-78 | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | — | 56 | 2026 |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | Cannula internal cooling · Controller, Foot, Handpiece And Cord · DEMO OsseoSet 200 (WS-75) SI-923, 230V · DEMO OsseoSet 200 SI-923, 230V · +6 | 94 | 2026 |
| Hiossen Inc. | United States | Manufacturer | SM3 | 26 | 2026 |
| Sybron Dental Specialties | United States | Contract manufacturer | elements e-motion | 203 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Contract manufacturer | Contra Angle NSK | 7 | 2025 |
| ADIN DENTAL IMPLANT SYSTEMS Ltd | Israel | Foreign exporter | x-cube | 3 | 2026 |
| DIO Corporation | South Korea | Foreign exporter | Implant Air · SURGICUBE | 14 | 2023 |
| DCI International LLC | United States | Manufacturer | Assy, Nsk Display, S5 Dr · Kit, Motor, Electric, NSK NLZ E, Mobile DR, Left · Kit, Motor, Electric, NSK NLZ E, Mobile DR, Right · Kit, Motor, Electric, NSK NLZ E, Series 4, Left · +17 | 1 | 2025 |
| Aseptico, Inc. | United States | Contract manufacturer | AHP-85-SS Handpiece, contra-and right angle attachment, dental | 17 | 2015 |
| Vector Research & Development | United States | Repacker / relabeler | Vector | 1 | 2002 |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Dental Electric Motor · Dental Electric Motor / Dental Implantation System | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | Implant Air · MT-2 | — | — |
| GoldenDent | United States | Repacker / relabeler | Dental Electric Motor, MT2, MT3, Controller Foot, Handpience and Cord, Contra and Right Angle attachment | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Contra-angle handpiece: WJ-45L, WJ-45TL;Dental Electric Motor:MT2,M2 Pro · Dental Implant Unit (Model: Implant Air);Contra-angle handpiece: WP-1L, WJ-11L | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | — | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | Brasseler Electric Motor | — | — |
| Vietmedical Distribution Joint Stock Company | Vietnam | Foreign exporter | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 · IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | — | — |
| Biocells Discoveries Internacional (Biocells) | Ecuador | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Transmedic Healthcare Sdn. Bhd. | Malaysia | Foreign exporter | — | — | — |
| Tribe Medical Group | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 Oct 2026 | K260027 | Firstar Dental Electric Motor | Firstar Dental Company |
| 30 Jan 2026 | K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. |
| 12 Jan 2026 | K251701 | Star E900 Electric System | Dentalez, Inc. |
| 25 Aug 2025 | K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. |
| 18 Jul 2025 | K231562 | ELEC ENGINE (Model: ISE-170L) | MICRO-NX Co., Ltd. |
| 11 Apr 2025 | K242646 | Dental Implant Unit | Guilin AestheDent Medical Instruments Co., Ltd |
| 24 Jun 2024 | K233288 | NLZ Built-In Motor System | Nakanishi, Inc. |
| 20 Jun 2024 | K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. |
| 1 Apr 2024 | K230895 | 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, | Cefla S.C. |
| 11 Mar 2024 | K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. |
| 21 Nov 2022 | K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 27 Sep 2022 | K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan COXO Medical Instrument Co., Ltd. |
| 9 May 2022 | K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | Cefla S.C. |
| 11 Mar 2022 | K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. |
| 7 Feb 2022 | K201191 | ELEC-LED | MICRO-NX Co., Ltd. |
| 13 Jan 2022 | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 21 May 2021 | K201192 | Impla-NX (Model: ISE-270M) | MICRO-NX Co., Ltd. |
| 11 Feb 2021 | K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. |
| 4 Sep 2020 | K193341 | iCTmotor (WL-1) | Dentium USA |
| 25 Jul 2019 | K180845 | Maxima Electric System | Handpiece Headquarters |
| 26 Mar 2019 | K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH |
| 19 Jun 2018 | K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. |
| 31 Aug 2017 | K163402 | NLZ Motor System | Nakanishi, Inc. |
| 11 May 2017 | K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. |
| 21 Feb 2017 | K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh |
| 10 Feb 2017 | K161213 | XSmart iQ | Dentsply Sirona, Inc. |
| 23 Nov 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Bürmoos GmbH |
| 24 Apr 2015 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. |
| 15 Aug 2014 | K140308 | MASTERSURG / EXPERTSURG | Kaltenbach & Voigt GmbH |
| 28 May 2014 | K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | A-dec, Inc. |
| 29 Apr 2014 | K132570 | ELECTRIC HANDPIECE SYSTEM | Ttbio Corp. |
| 16 Aug 2013 | K123608 | ENDO E CLASS | Saeyang Microtech Co., Ltd. |
| 10 Jan 2012 | K111623 | I-ENDO DUAL | Satelec - Acteon Group |
| 19 Aug 2011 | K103027 | ELECTROTORQUE TLC | Kaltenbach & Voigt GmbH |
| 26 May 2011 | K103653 | E3 TORQUE CONTROL MOTOR | Dentsply International, Inc. |
| 23 Mar 2011 | K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT | Institut Straumann AG |
| 3 Dec 2010 | K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | Bonart Co., Ltd. |
| 15 Dec 2009 | K092214 | CHIROPRO L SYSTEM | Bien-Air Dental, SA |
| 21 Sep 2009 | K092758 | X-CUBE | Saeshin Precision Co., Ltd. |
| 13 Aug 2009 | K090727 | IMM DENTAL IRRIGATION TUBING SET | Innovative Medical Manufacturing Co. |
| 24 Jul 2009 | K090937 | E-STATIS 40 SYSTEM | Coltene/Whaledent AG |
| 18 Feb 2009 | K083252 | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM | Dentalez Group, Stardental Division |
| 3 May 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH |
| 13 Jan 2006 | K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | W&H Dentalwerk Buermoos GmbH |
| 7 Jun 2004 | K041124 | IRRIGATION TUBING SET 2.2M AND 3.8M | W&H Dentalwerk Bürmoos GmbH |
| 21 May 2004 | K040153 | I-TEC PORTABLE DENTAL OPERATORY | Indigenous Peoples Technology and Education Center |
| 3 Dec 2003 | K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | A-dec, Inc. |
| 19 Aug 2003 | K031584 | SIROTORQUE L | Dentsply Sirona, Inc. |
| 3 May 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | W&H Dentalwerk Buermoos GmbH |
| 8 Apr 2002 | K020327 | SURGIC IV IMPLANT CONTROL UNIT | Nakanishi, Inc. |
| 11 Sep 2001 | K011926 | ELEC-MATE E | Nakanishi, Inc. |
| 7 Feb 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH |
| 3 Feb 2000 | K000120 | PRO-TORQ | Micro Motors, Inc. |
| 31 Jan 2000 | K992648 | ROTARY MASTER | J. Morita USA, Inc. |
| 9 Jun 1999 | K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | Nsk Nakanishi, Inc. |
| 22 Jan 1998 | K972889 | ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) | W & H Dentalwerk |
| 30 Oct 1997 | K972924 | SURGIC II IMPLANT CONTROL UNIT | Nsk Nakanishi, Inc. |
| 3 Mar 1997 | K964860 | MARK 20 AND MARK 25 HAND ENGINE CONTROLLER | Bell Intl., Inc. |
| 28 Feb 1997 | K964863 | MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN | Bell Intl., Inc. |
| 27 Feb 1991 | K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH | Site Microsurgical Systems, Inc. |
| 14 May 1979 | K790322 | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 | Applied Medical Research |
| 28 Jan 1977 | K770129 | SPRINT S-2 INSTRU. CENTER (MODEL 92329) | Chemetron Health Systems |
Official records: FDA product classification for EBW · 21 CFR 872.4200.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026