Product code EKX
- Device name
- Handpiece, Direct Drive, Ac-Powered
- 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 |
|---|---|---|---|
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-10-16 |
| K251597 | InnerView System | Perimetrics, Inc. | 2025-09-18 |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | 2025-08-22 |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | 2025-04-24 |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025-03-21 |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | 2024-12-20 |
| K222688 | The Trust | Genoss Co., Ltd. | 2024-08-09 |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024-07-24 |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | 2024-07-09 |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023-11-09 |
| K232657 | InnerView LC | Perimetrics, Inc. | 2023-09-01 |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | 2023-05-18 |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | 2023-04-26 |
| K210475 | EQ-M | Meta Systems Co., Ltd. | 2022-09-21 |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | 2022-09-19 |
| K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. | 2022-06-24 |
| K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-12-17 |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-05-10 |
| K192649 | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. | 2021-03-12 |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | 2021-02-24 |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | 2021-01-29 |
| K191276 | Dental Electrical Motor iRoot Pro | Changzhou Bomedent Medical Technology Co.,Ltd | 2020-06-30 |
| K181888 | Osstell Beacon | Osstell AB | 2019-08-22 |
| K180682 | AeroPro Cordless Prophy System | Premier Dental Company Products | 2019-02-27 |
| K180953 | AnyCheck IMT-100 | Dms Co., Ltd. | 2019-02-20 |
| K173920 | LS OIL | J. Morita USA, Inc. | 2018-10-11 |
| K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | 2018-08-20 |
| K180527 | IS3 | Hiossen, Inc. | 2018-05-16 |
| K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | 2017-09-11 |
| K161500 | MEG-TORQ | Micro-Nx Co., Ltd. | 2017-02-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809260475458 | E-CUBE | Saeshin Precision Co., Ltd. | 2026-03-31 |
| 09010522000892 | Osstell IDx Instrument | Osstell AB | 2022-11-01 |
| 09010522001141 | DIO IDx Instrument | Osstell AB | 2022-11-01 |
| 09010522001370 | Osstell SmartPeg Type 25 | Osstell AB | 2022-09-02 |
| 09010522001301 | Osstell SmartPeg Type 16 | Osstell AB | 2022-09-02 |
| 09010522001318 | Osstell SmartPeg Type 17 | Osstell AB | 2022-09-02 |
| 09010522001325 | Osstell SmartPeg Type 18 | Osstell AB | 2022-09-02 |
| 09010522001332 | Osstell SmartPeg Type 21 | Osstell AB | 2022-09-02 |
| 09010522001349 | Osstell SmartPeg Type 22 | Osstell AB | 2022-09-02 |
| 09010522001356 | Osstell SmartPeg Type 23 | Osstell AB | 2022-09-02 |
| 09010522001363 | Osstell SmartPeg Type 24 | Osstell AB | 2022-09-02 |
| 09010522001288 | Osstell SmartPeg Type 13 | Osstell AB | 2022-09-02 |
| 09010522001387 | Osstell SmartPeg Type 26 | Osstell AB | 2022-09-02 |
| 09010522001394 | Osstell SmartPeg Type 27 | Osstell AB | 2022-09-02 |
| 09010522001400 | Osstell SmartPeg Type 28 | Osstell AB | 2022-09-02 |
| 09010522001417 | Osstell SmartPeg Type 30 | Osstell AB | 2022-09-02 |
| 09010522001424 | Osstell SmartPeg Type 31 | Osstell AB | 2022-09-02 |
| 09010522001295 | Osstell SmartPeg Type 15 | Osstell AB | 2022-09-02 |
| 09010522001271 | Osstell SmartPeg Type 12 | Osstell AB | 2022-09-02 |
| 09010522001264 | Osstell SmartPeg Type 11 | Osstell AB | 2022-09-02 |
| 09010522001257 | Osstell SmartPeg Type 10 | Osstell AB | 2022-09-02 |
| 09010522001240 | Osstell SmartPeg Type 09 | Osstell AB | 2022-09-02 |
| 09010522001233 | Osstell SmartPeg Type 08 | Osstell AB | 2022-09-02 |
| 09010522001226 | Osstell SmartPeg Type 07 | Osstell AB | 2022-09-02 |
| 09010522001219 | Osstell SmartPeg Type 06 | Osstell AB | 2022-09-02 |
| 09010522001202 | Osstell SmartPeg Type 05 | Osstell AB | 2022-09-02 |
| 09010522001196 | Osstell SmartPeg Type 04 | Osstell AB | 2022-09-02 |
| 09010522001189 | Osstell SmartPeg Type 03 | Osstell AB | 2022-09-02 |
| 09010522001097 | MEGA ISQ II Instrument | Osstell AB | 2022-09-02 |
| 09010522000885 | Osstell Beacon Instrument | Osstell AB | 2022-09-02 |