Product code EBW
- Device name
- Controller, Foot, Handpiece And Cord
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4200
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | 2026-01-30 |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | 2026-01-12 |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025-08-25 |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | 2025-07-18 |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | 2025-04-11 |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024-06-24 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | 2024-06-20 |
| 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. | 2024-04-01 |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | 2024-03-11 |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-11-21 |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | 2022-09-27 |
| 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. | 2022-05-09 |
| K202075 | Dental Electric Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2022-03-11 |
| K201191 | ELEC-LED | Micro-Nx Co., Ltd. | 2022-02-07 |
| K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2022-01-13 |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | 2021-05-21 |
| K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | 2021-02-11 |
| K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | 2020-09-04 |
| K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | 2019-07-25 |
| K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | 2019-03-26 |
| K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | 2018-06-19 |
| K163402 | NLZ Motor System | Nakanishi, Inc. | 2017-08-31 |
| K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017-05-11 |
| K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | 2017-02-21 |
| K161213 | XSmart iQ | Dentsply Sirona | 2017-02-10 |
| K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Burmoos GmbH | 2016-11-23 |
| K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015-04-24 |
| K140308 | MASTERSURG / EXPERTSURG | Kaltenbach & Voigt GmbH | 2014-08-15 |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | A-Dec, Inc. | 2014-05-28 |
| K132570 | ELECTRIC HANDPIECE SYSTEM | Ttbio Corp. | 2014-04-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033837935896 | Anthos | CEFLA SOCIETA' COOPERATIVA | 2026-04-16 |
| 08033837935902 | Stern Weber | CEFLA SOCIETA' COOPERATIVA | 2026-04-16 |
| 08033837935919 | Stern Weber | CEFLA SOCIETA' COOPERATIVA | 2026-04-16 |
| 08033837935926 | Castellini | CEFLA SOCIETA' COOPERATIVA | 2026-04-16 |
| 08033837935933 | Castellini | CEFLA SOCIETA' COOPERATIVA | 2026-04-16 |
| 08033837935889 | Anthos | CEFLA SOCIETA' COOPERATIVA | 2026-04-16 |
| 08809260475519 | X-CUBE | Saeshin Precision Co., Ltd. | 2026-04-02 |
| 08809260475410 | TRAUS | Saeshin Precision Co., Ltd. | 2026-03-25 |
| 08809260475403 | AHP-85-SS | Saeshin Precision Co., Ltd. | 2026-03-25 |
| 10194665008444 | A-dec | A-DEC, INC. | 2026-02-19 |
| J00716010690011 | CABLE MX-i LED | Bien-Air Dental SA | 2023-02-01 |
| J021062400001 | Contra-angle Handpiece Osteomed 80:1 | W & H Dentalwerk Bürmoos GmbH | 2019-09-09 |
| J021060680001 | Contra-angle Handpiece Osteomed 20:1 | W & H Dentalwerk Bürmoos GmbH | 2019-09-08 |
| J021050833001 | S-N1 for SI-95 | W & H Dentalwerk Bürmoos GmbH | 2019-09-08 |
| 08800000995212 | SM3 | Osstem Implant Co., Ltd._Gasan Branch | 2019-04-25 |
| 08800000995229 | SM3 | Osstem Implant Co., Ltd._Gasan Branch | 2019-04-25 |
| 08800000995236 | SM3 | Osstem Implant Co., Ltd._Gasan Branch | 2019-04-25 |
| 08809260470125 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470002 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470019 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470026 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470033 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470118 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470101 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470095 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470088 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470071 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470064 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470057 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470040 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |