EBW · Controller, Foot, Handpiece And Cord
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EBW |
|---|---|
| Device Name | Controller, Foot, Handpiece And Cord |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
Classification Rationale
Class I.
Cleared Devices (61)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | Jan 30, 2026 | SESE |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | Jan 12, 2026 | SESE |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | Aug 25, 2025 | SESE |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | Jul 18, 2025 | SESE |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | Apr 11, 2025 | SESE |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | Jun 24, 2024 | SESE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | Jun 20, 2024 | SESE |
| 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. | Apr 1, 2024 | SESE |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | Mar 11, 2024 | SESE |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | Nov 21, 2022 | SESE |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | Sep 27, 2022 | SESE |
| 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. | May 9, 2022 | SESE |
| K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | Mar 11, 2022 | SESE |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | Feb 7, 2022 | SESE |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | Jan 13, 2022 | SESE |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | May 21, 2021 | SESE |
| K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | Feb 11, 2021 | SESE |
| K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | Sep 4, 2020 | SESE |
| K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | Jul 25, 2019 | SESE |
| K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | Mar 26, 2019 | SESE |
| K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | Jun 19, 2018 | SESE |
| K163402 | NLZ Motor System | Nakanishi, Inc. | Aug 31, 2017 | SESE |
| K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | May 11, 2017 | SESE |
| K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | Feb 21, 2017 | SESE |
| K161213 | XSmart iQ | Dentsply Sirona | Feb 10, 2017 | SESE |
| K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | Nov 23, 2016 | SESE |
| K141482 | KI-20 | Saeyang Microtech Co., Ltd. | Apr 24, 2015 | SESE |
| K140308 | MASTERSURG / EXPERTSURG | Kaltenbach & Voigt GmbH | Aug 15, 2014 | SESE |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | A-Dec, Inc. | May 28, 2014 | SESE |
| K132570 | ELECTRIC HANDPIECE SYSTEM | Ttbio Corp. | Apr 29, 2014 | SESE |
| K123608 | ENDO E CLASS | Saeyang Microtech Co., Ltd. | Aug 16, 2013 | SESE |
| K111623 | I-ENDO DUAL | Satelec - Acteon Group | Jan 10, 2012 | SESE |
| K103027 | ELECTROTORQUE TLC | Kaltenbach & Voigt GmbH | Aug 19, 2011 | SESE |
| K103653 | E3 TORQUE CONTROL MOTOR | Dentsply International, Inc. | May 26, 2011 | SESE |
| K102241 | ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT | Anthogyr Sas | Mar 23, 2011 | SESE |
| K100785 | BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES | Bonart Co., Ltd. | Dec 3, 2010 | SESE |
| K092214 | CHIROPRO L SYSTEM | Bien-Air Dental, SA | Dec 15, 2009 | SESE |
| K092758 | X-CUBE | Saeshin Precision Co., Ltd. | Sep 21, 2009 | SESE |
| K090727 | IMM DENTAL IRRIGATION TUBING SET | Innovative Medical Manufacturing Co. | Aug 13, 2009 | SESE |
| K090937 | E-STATIS 40 SYSTEM | Scican , Ltd. | Jul 24, 2009 | SESE |
| K083252 | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM | Dentalez Group, Stardental Division | Feb 18, 2009 | SESE |
| K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH | May 3, 2006 | SESE |
| K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | W&H Dentalwerk Buermoos GmbH | Jan 13, 2006 | SESE |
| K041124 | IRRIGATION TUBING SET 2.2M AND 3.8M | W&H Dentalwerk Burmoos | Jun 7, 2004 | SESE |
| K040153 | I-TEC PORTABLE DENTAL OPERATORY | Indigenous Peoples Technology and Education Center | May 21, 2004 | SESE |
| K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | A-Dec, Inc. | Dec 3, 2003 | SESE |
| K031584 | SIROTORQUE L | Sirona Dental Systems GmbH | Aug 19, 2003 | SESE |
| K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | W&H Dentalwerk Buermoos GmbH | May 3, 2002 | SESE |
| K020327 | SURGIC IV IMPLANT CONTROL UNIT | Nakanishi, Inc. | Apr 8, 2002 | SESE |
| K011926 | ELEC-MATE E | Nakanishi, Inc. | Sep 11, 2001 | SESE |
| K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | Feb 7, 2001 | SESE |
| K000120 | PRO-TORQ | Micro Motors, Inc. | Feb 3, 2000 | SESE |
| K992648 | ROTARY MASTER | J. Morita USA, Inc. | Jan 31, 2000 | SESE |
| K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | Nsk Nakanishi, Inc. | Jun 9, 1999 | SESE |
| K972889 | ELCOMED 100 TYPES 9925 (W&H- AND INNOVA-VERSION) AND 9927 (ASTRA-VERSION), ELCOMED 200 TYPE 9926 (W&H-VERSION) | W & H Dentalwerk | Jan 22, 1998 | SESE |
| K972924 | SURGIC II IMPLANT CONTROL UNIT | Nsk Nakanishi, Inc. | Oct 30, 1997 | SESE |
| K964860 | MARK 20 AND MARK 25 HAND ENGINE CONTROLLER | Bell Intl., Inc. | Mar 3, 1997 | SESE |
| K964863 | MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN | Bell Intl., Inc. | Feb 28, 1997 | SESE |
| K905620 | MODIFIED SITE PERISTALTIC FOOTSWITCH | Site Microsurgical Systems, Inc. | Feb 27, 1991 | SESE |
| K790322 | OPTIONAL ACCESSORY FOOT SWITCH MODEL 100 | Applied Medical Research | May 14, 1979 | SESE |
| K770129 | SPRINT S-2 INSTRU. CENTER (MODEL 92329) | Chemetron Health Systems | Jan 28, 1977 | SESE |
Top Applicants
- Nakanishi, Inc. — 7 clearances
- W&H Dentalwerk Buermoos GmbH — 5 clearances
- Saeshin Precision Co., Ltd. — 3 clearances
- Micro-Nx Co., Ltd. — 3 clearances
- Saeyang Microtech Co., Ltd. — 2 clearances
