Handpiece, Direct Drive, Ac-Powered
Regulation 872.4200
1510(k)s in 12 months (90 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EKX
| Company | 510(k)s | Recalls |
|---|---|---|
| J. Morita USA, Inc. | 6 | 0 |
| Aseptico, Inc. | 5 | 0 |
| Osstell AB | 5 | 0 |
| Perimetrics, Inc. | 3 | 0 |
| Saeshin Precision Co., Ltd. | 3 | 0 |
| W&H Dentalwerk Buermoos GmbH | 3 | 0 |
| Advanced Technology Research (A.T.R.) S.R.L. | 2 | 0 |
| Chiron Vision Corp. | 2 | 0 |
| Dentsply Sirona | 2 | 0 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2026 | K261987 | Reusable SmartPeg Osstell AB, SE | EKX |
| Oct 16, 2025 | K252223 | Alpha Endo Handpiece (Alpha Endo) SHENZHEN SUPERLINE TECHNOLOGY CO., LTD., CN | EKX |
| Sep 18, 2025 | K251597 | InnerView System Perimetrics, Inc. | EKX |
| Aug 22, 2025 | K243692 | EnDrive (EnDriveUS) Advanced Technology Research (A.T.R.) S.R.L., IT | EKX |
| Apr 24, 2025 | K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) Shenzhen Rogin Medical Co., Ltd., CN | EKX |
| Mar 21, 2025 | K241065 | ChecQ (AC100) Dentis Co., Ltd., KR | EKX |
| Dec 20, 2024 | K243911 | HPR Cordless Hygiene Handpiece Handpiece Headquarters | EKX |
| Aug 9, 2024 | K222688 | The Trust Genoss Co., Ltd., KR | EKX |
| Jul 24, 2024 | K233865 | X-Smart Pro; X-Smart Pro+ Dentsply Sirona, Inc. | EKX |
| Jul 9, 2024 | K232551 | EM-07 Cordless Endo Motor Forum Engineering Technologies (96) , Ltd., IL | EKX |
| Nov 9, 2023 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit Micro-Nx Co., Ltd., KR | EKX |
| Sep 1, 2023 | K232657 | InnerView LC Perimetrics, Inc. | EKX |
| May 18, 2023 | K220829 | Endo Motor Foshan Coxo Medical Instrument Co., Ltd., CN | EKX |
| Apr 26, 2023 | K222548 | Endo Motor Shenzhen Perfect Medical Instruments Co., Ltd., CN | EKX |
| Sep 21, 2022 | K210475 | EQ-M Meta Systems Co., Ltd., KR | EKX |
| Sep 19, 2022 | K213897 | Pro M Class Saeyang Microtech Co., Ltd., KR | EKX |
| Jun 24, 2022 | K212043 | TRAUS ENDO Saeshin Precision Co., Ltd., KR | EKX |
| Dec 17, 2021 | K211531 | Cordless Prophy System, Model: i-Polish Guilin Woodpecker Medical Instrument Co., Ltd., CN | EKX |
| May 10, 2021 | K203320 | Endo Motor Guilin Woodpecker Medical Instrument Co., Ltd., CN | EKX |
| Mar 12, 2021 | K192649 | Endo Motor Foshan Cicada Dental Instrument Co, Ltd., CN | EKX |
| Feb 24, 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H W&H Dentalwerk Buermoos GmbH, AT | EKX |
| Jan 29, 2021 | K201993 | E-connect S Endo Motor with built-in Apex Locator Changzhou Sifary Medical Technology Co., Ltd., CN | EKX |
| Jun 30, 2020 | K191276 | Dental Electrical Motor iRoot Pro Changzhou Bomedent Medical Technology Co.,Ltd, CN | EKX |
| Aug 22, 2019 | K181888 | Osstell Beacon Osstell AB, SE | EKX |
| Feb 27, 2019 | K180682 | AeroPro Cordless Prophy System Premier Dental Company Products | EKX |
| Feb 20, 2019 | K180953 | AnyCheck IMT-100 Dms Co., Ltd., KR | EKX |
| Oct 11, 2018 | K173920 | LS OIL J. Morita USA, Inc. | EKX |
| Aug 20, 2018 | K171377 | Young INFINITY Cordless Handpiece System Young Dental Manufacturing Co. 1, LLC | EKX |
| May 16, 2018 | K180527 | IS3 Hiossen, Inc. | EKX |
| Sep 11, 2017 | K170275 | Tri Auto ZX2 J. Morita USA, Inc. | EKX |
| Feb 22, 2017 | K161500 | MEG-TORQ Micro-Nx Co., Ltd., KR | EKX |
| Sep 27, 2016 | K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology Dentsply Sirona | EKX |
| Aug 12, 2016 | K153285 | EMS-200 Meta Systems Co., Ltd., KR | EKX |
| Jan 7, 2016 | K143445 | Tellos ISQ Buddy Tellos Medical AB, SE | EKX |
| Jun 29, 2015 | K143411 | TRAUS ENDO Saeshin Precision Co., Ltd., KR | EKX |
| May 28, 2015 | K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) Aseptico, Inc. | EKX |
| Feb 19, 2015 | K142358 | Osstell IDx Osstell AB, SE | EKX |
| Dec 31, 2014 | K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM Aseptico, Inc. | EKX |
| Sep 19, 2014 | K133298 | ENDO SMART Meta Biomed, Inc. | EKX |
| Apr 9, 2014 | K132401 | MEGA ISQ Osstell AB | EKX |
| Sep 12, 2013 | K131578 | IPROPHY MOBILE Nakanishi, Inc. | EKX |
| Aug 16, 2013 | K123582 | ENDO A CLASS Saeyang Microtech Co., Ltd. | EKX |
| May 4, 2012 | K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE J. Morita USA, Inc. | EKX |
| Feb 15, 2012 | K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 Nakanishi, Inc. | EKX |
| Aug 19, 2011 | K111616 | E-CUBE Saeshin Precision Co., Ltd., KR | EKX |
| Jun 14, 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM Aseptico, Inc. | EKX |
| Jun 6, 2011 | K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM Dentsply International, Inc. | EKX |
| Feb 28, 2011 | K103399 | GENERAL DENISTRY MOTOR Aseptico, Inc. | EKX |
| Jul 9, 2010 | K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 W&H Dentalwerk Buermoos GmbH, AT | EKX |
| Jun 30, 2010 | K101612 | ZEN CORDLESS PROPHY SYSTEM Discus Dental, LLC | EKX |
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