Controller, Foot, Handpiece And Cord
FDA product code EBW · Class I (low risk) · 21 CFR 872.4200 · Dental
61510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Nakanishi, Inc. 7
- W&H Dentalwerk Buermoos GmbH 5
- Saeshin Precision Co., Ltd. 3
- Micro-Nx Co., Ltd. 3
- Kaltenbach & Voigt GmbH 2
- Saeyang Microtech Co., Ltd. 2
- Bell Intl., Inc. 2
- Nsk Nakanishi, Inc. 2
- Guilin Woodpecker Medical Instrument Co., Ltd. 2
- A-Dec, Inc. 2
- W&H Dentalwerk Burmoos GmbH 2
- Cefla S.C. 2
- Dentsply Sirona 2
- Sirona Dental Systems GmbH 1
- Dentalez, Inc., Stardental Division 1
- Innovative Medical Manufacturing Co. 1
- Indigenous Peoples Technology and Education Center 1
- J. Morita USA, Inc. 1
- W & H Dentalwerk 1
- Site Microsurgical Systems, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10)EBW · Traditional | Saeshin Precision Co., Ltd. | 01/30/2026SE |
| K251701 | Star E900 Electric SystemEBW · Traditional | Dentalez, Inc., Stardental Division | 01/12/2026SE |
| K251811 | Motor and Apex Module (MaAM)EBW · Traditional | Dentsply Sirona, Inc. | 08/25/2025SE |
| K231562 | ELEC ENGINE (Model: ISE-170L)EBW · Special | Micro-Nx Co., Ltd. | 07/18/2025SE |
| K242646 | Dental Implant UnitEBW · Traditional | Guilin Aesthedent Medical Instruments Co., Ltd. | 04/11/2025SE |
| K233288 | NLZ Built-In Motor SystemEBW · Traditional | Nakanishi, Inc. | 06/24/2024SE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional | Nakanishi, Inc. | 06/20/2024SE |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional | Cefla S.C. | 04/01/2024SE |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional | Codent Technical Industry Co., Ltd. | 03/11/2024SE |
| K211358 | Implanter incl. AccessoriesEBW · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 11/21/2022SE |
| K220831 | Dental Implantation Systems, Dental Electrical MotorsEBW · Traditional | Foshan Coxo Medical Instrument Co., Ltd. | 09/27/2022SE |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…EBW · Traditional | Cefla S.C. | 05/09/2022SE |
| K202075 | Dental Electric MotorEBW · Traditional | Foshan Cicada Dental Instrument Co, Ltd. | 03/11/2022SE |
| K201191 | Elec-LedEBW · Traditional | Micro-Nx Co., Ltd. | 02/07/2022SE |
| K203706 | Dental Electric MotorEBW · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 01/13/2022SE |
| K201192 | Impla-NX (Model: ISE-270M)EBW · Traditional | Micro-Nx Co., Ltd. | 05/21/2021SE |
| K201292 | Traus SIP20EBW · Traditional | Saeshin Precision Co., Ltd. | 02/11/2021SE |
| K193341 | iCTmotor (WL-1)EBW · Traditional | Dentium Co., Ltd. | 09/04/2020SE |
| K180845 | Maxima Electric SystemEBW · Traditional | Handpiece Headquarters - Hpr, Inc. | 07/25/2019SE |
| K181858 | Electric Handpiece MotorEBW · Traditional | W&H Dentalwerk Buermoos GmbH | 03/26/2019SE |
| K173905 | Surgic Pro, Surgic Pro+EBW · Traditional | Nakanishi, Inc. | 06/19/2018SE |
| K163402 | NLZ Motor SystemEBW · Traditional | Nakanishi, Inc. | 08/31/2017SE |
| K163131 | A-dec NLZ Electric Motor SystemEBW · Traditional | Nakanishi, Inc. | 05/11/2017SE |
| K163317 | ELECTROmaticEBW · Traditional | Kaltenbach & Voigt Gmgh | 02/21/2017SE |
| K161213 | XSmart iQEBW · Traditional | Dentsply Sirona | 02/10/2017SE |
| K161957 | W&H Implantmed SI-1015 incl. AccessoriesEBW · Traditional | W&H Dentalwerk Burmoos GmbH | 11/23/2016SE |
| K141482 | KI-20EBW · Traditional | Saeyang Microtech Co., Ltd. | 04/24/2015SE |
| K140308 | Mastersurg / ExpertsurgEBW · Traditional | Kaltenbach & Voigt GmbH | 08/15/2014SE |
| K133776 | A-Dec/W&H Electric Handpiece MotorEBW · Special | A-Dec, Inc. | 05/28/2014SE |
| K132570 | Electric Handpiece SystemEBW · Abbreviated | Ttbio Corp. | 04/29/2014SE |
| K123608 | Endo E ClassEBW · Traditional | Saeyang Microtech Co., Ltd. | 08/16/2013SE |
| K111623 | I-Endo DualEBW · Traditional | Satelec - Acteon Group | 01/10/2012SE |
| K103027 | Electrotorque TLCEBW · Traditional | Kaltenbach & Voigt GmbH | 08/19/2011SE |
| K103653 | E3 Torque Control MotorEBW · Traditional | Dentsply International, Inc. | 05/26/2011SE |
| K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor UnitEBW · Traditional | Anthogyr Sas | 03/23/2011SE |
| K100785 | Bonart Model ART-IM1 Implantor System & AccessoriesEBW · Traditional | Bonart Co., Ltd. | 12/03/2010SE |
| K092214 | Chiropro L SystemEBW · Traditional | Bien-Air Dental, SA | 12/15/2009SE |
| K092758 | X-CubeEBW · Traditional | Saeshin Precision Co., Ltd. | 09/21/2009SE |
| K090727 | Imm Dental Irrigation Tubing SetEBW · Traditional | Innovative Medical Manufacturing Co. | 08/13/2009SE |
| K090937 | E-Statis 40 SystemEBW · Traditional | Scican , Ltd. | 07/24/2009SE |
| K083252 | Nutorque Programmable Electric SystemEBW · Traditional | Dentalez Group, Stardental Division | 02/18/2009SE |
| K060287 | Drilltech, Ism, Implantunit, Zimmer Surgical Motor SystemEBW · Traditional | W&H Dentalwerk Buermoos GmbH | 05/03/2006SE |
| K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesEBW · Traditional | W&H Dentalwerk Buermoos GmbH | 01/13/2006SE |
| K041124 | Irrigation Tubing Set 2.2M and 3.8MEBW · Traditional | W&H Dentalwerk Burmoos | 06/07/2004SE |
| K040153 | I-Tec Portable Dental OperatoryEBW · Traditional | Indigenous Peoples Technology and Education Center | 05/21/2004SE |
| K032572 | A-Dec/W&H Electric Motor, Model EA-50LTEBW · Traditional | A-Dec, Inc. | 12/03/2003SE |
| K031584 | Sirotorque LEBW · Traditional | Sirona Dental Systems GmbH | 08/19/2003SE |
| K014068 | Elcomed, Models SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115EBW · Traditional | W&H Dentalwerk Buermoos GmbH | 05/03/2002SE |
| K020327 | Surgic IV Implant Control UnitEBW · Traditional | Nakanishi, Inc. | 04/08/2002SE |
| K011926 | Elec-Mate EEBW · Traditional | Nakanishi, Inc. | 09/11/2001SE |
| K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)EBW · Traditional | W&H Dentalwerk Buermoos GmbH | 02/07/2001SE |
| K000120 | Pro-TorqEBW · Special | Micro Motors, Inc. | 02/03/2000SE |
| K992648 | Rotary MasterEBW · Traditional | J. Morita USA, Inc. | 01/31/2000SE |
| K990954 | Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 SetEBW · Traditional | Nsk Nakanishi, Inc. | 06/09/1999SE |
| K972889 | Elcomed 100 Types 9925 (W&H- and Innova-Version) and 9927 (Astra-Version), Elcomed 200…EBW · Traditional | W & H Dentalwerk | 01/22/1998SE |
| K972924 | Surgic II Implant Control UnitEBW · Traditional | Nsk Nakanishi, Inc. | 10/30/1997SE |
| K964860 | Mark 20 and Mark 25 Hand Engine ControllerEBW · Traditional | Bell Intl., Inc. | 03/03/1997SE |
| K964863 | Model 45E Handengine & Controller, Model 45EH Handengine & Controller, Model RX-100…EBW · Traditional | Bell Intl., Inc. | 02/28/1997SE |
| K905620 | Modified Site Peristaltic FootswitchEBW · Traditional | Site Microsurgical Systems, Inc. | 02/27/1991SE |
| K790322 | Optional Accessory Foot Switch Model 100EBW · Traditional | Applied Medical Research | 05/14/1979SE |
| K770129 | Sprint S-2 Instru. Center (Model 92329)EBW · Traditional | Chemetron Health Systems | 01/28/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1351-2018 Class II | Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with…During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual… | W & H DentalWerk Burmoos GMBH - Site 1 | 12/21/2017Terminated |
| Z-0273-2014 Class II | Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and…The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with… | Nobel Biocare Usa Llc | 10/24/2013Terminated |