FDA 510(k) Applications for Medical Device Product Code "EKX"
(Handpiece, Direct Drive, Ac-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K033597 | ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. | ATR 5000, LC 5000, IMPLANT SYSTEM | 11/25/2003 |
| K041279 | ANTHOGYR | IMPLANTEO IMPLANTOLOGY MOTOR | 09/23/2004 |
| K082325 | APEXUM LTD. | APEXUM ABLATOR | 04/21/2009 |
| K111078 | ASEPTICO, INC. | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | 06/14/2011 |
| K142124 | ASEPTICO, INC. | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | 12/31/2014 |
| K150129 | Aseptico, Inc. | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | 05/28/2015 |
| K030163 | ASEPTICO, INC. | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | 03/03/2003 |
| K103399 | ASEPTICO, INC. | GENERAL DENISTRY MOTOR | 02/28/2011 |
| K091913 | BY DENTAL SRL | HI TECH IMPLANT, HT PHYSIO IMPLANT | 10/30/2009 |
| K191276 | ChangZhou BoMedent Medical Technology Co., Ltd. | Dental Electrical Motor iRoot Pro | 06/30/2020 |
| K201993 | Changzhou Sifary Medical Technology Co., Ltd. | E-connect S Endo Motor with built-in Apex Locator | 01/29/2021 |
| K092833 | DENTAMERICA | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | 01/07/2010 |
| K241065 | DENTIS Co., Ltd. | ChecQ (AC100) | 03/21/2025 |
| K110753 | DENTSPLY INTERNATIONAL, INC. | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | 06/06/2011 |
| K092614 | DENTSPLY INTERNTIONAL | X-SMART EASY | 12/02/2009 |
| K160825 | DENTSPLY SIRONA | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | 09/27/2016 |
| K233865 | Dentsply Sirona Inc. | X-Smart Pro; X-Smart Pro+ | 07/24/2024 |
| K101612 | DISCUS DENTAL, LLC | ZEN CORDLESS PROPHY SYSTEM | 06/30/2010 |
| K180953 | DMS Co., Ltd. | AnyCheck IMT-100 | 02/20/2019 |
| K232551 | Forum Engineering Technologies (96) Ltd. | EM-07 Cordless Endo Motor | 07/09/2024 |
| K192649 | Foshan CICADA Dental Instrument Co., Ltd. | Endo Motor | 03/12/2021 |
| K220829 | Foshan COXO Medical Instrument Co., Ltd. | Endo Motor | 05/18/2023 |
| K222688 | Genoss Co., Ltd | The Trust | 08/09/2024 |
| K211531 | Guilin Woodpecker Medical Instrument Co., Ltd. | Cordless Prophy System, Model: i-Polish | 12/17/2021 |
| K203320 | Guilin Woodpecker Medical Instrument Co., Ltd. | Endo Motor | 05/10/2021 |
| K243911 | Handpiece Headquarters | HPR Cordless Hygiene Handpiece | 12/20/2024 |
| K180527 | Hiossen, Inc. | IS3 | 05/16/2018 |
| K033689 | INTEGRATION DIAGNOSTICS LTD | OSSTELL MENTOR RFA | 02/26/2004 |
| K003714 | INTEGRATION DIAGNOSTICS LTD | OSSTELL RESONANCE FREQUENCY ANALYZER | 08/09/2001 |
| K031204 | J. MORITA USA, INC. | DENTAPORT ZX | 08/21/2003 |
| K173920 | J. Morita USA, Inc. | LS OIL | 10/11/2018 |
| K071190 | J. MORITA USA, INC. | ROOT ZX II | 08/17/2007 |
| K112665 | J. MORITA USA, INC. | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | 05/04/2012 |
| K970339 | J. MORITA USA, INC. | TRI AUTO ZX | 06/04/1997 |
| K170275 | J. MORITA USA, INC. | Tri Auto ZX2 | 09/11/2017 |
| K031540 | LARES RESEARCH, INC. | APEX ELECTRIC HANDPIECE SYSTEM | 06/30/2003 |
| K050612 | LIGHTSPEED TECHNOLOGY, INC. | LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE | 05/04/2005 |
| K012944 | MEDITEAM AB | POWER DRIVE | 11/20/2001 |
| K133298 | META BIOMED, INC. | ENDO SMART | 09/19/2014 |
| K210475 | Meta Systems Co., Ltd | EQ-M | 09/21/2022 |
| K153285 | META SYSTEMS CO., LTD. | EMS-200 | 08/12/2016 |
| K161500 | MICRO-NX Co., Ltd | MEG-TORQ | 02/22/2017 |
| K232810 | Micro-NX Co., Ltd. | Dental Handpiece, Wireless Endodontic Handpiece, endoit | 11/09/2023 |
| K110278 | NAKANISHI, INC. | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 | 02/15/2012 |
| K131578 | NAKANISHI, INC. | IPROPHY MOBILE | 09/12/2013 |
| K081191 | NOUVAG AG | TCM ENDO 20 | 08/07/2008 |
| K042822 | NOUVAG AG | TCM ENDO V, MODEL 1534 | 12/22/2004 |
| K990646 | NSK NAKANISHI, INC. | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | 03/19/1999 |
| K990682 | NSK NAKANISHI, INC. | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | 03/24/1999 |
| K132401 | OSSTELL AB | MEGA ISQ | 04/09/2014 |
| K181888 | Osstell AB | Osstell Beacon | 08/22/2019 |
| K142358 | OSSTELL AB | Osstell IDx | 02/19/2015 |
| K082523 | OSSTELL AB | OSSTELL ISQ IMPLANT STABILITY METER | 09/26/2008 |
| K983413 | PARKELL, INC. | MODEL MS-1 HANDPIECE | 12/21/1998 |
| K232657 | Perimetrics, Inc | InnerView LC | 09/01/2023 |
| K072213 | PERIMETRICS, INC. | PERIMETRICS PERIOMETER | 08/29/2008 |
| K993188 | PHYTRON- ELEKTRONIK GMBH | ENDOSTEPPER 1 | 09/28/1999 |
| K180682 | Premier Dental Company Products | AeroPro Cordless Prophy System | 02/27/2019 |
| K111616 | SAESHIN PRECISION CO., LTD. | E-CUBE | 08/19/2011 |
| K212043 | Saeshin Precision Co., Ltd. | TRAUS ENDO | 06/24/2022 |
| K143411 | SAESHIN PRECISION CO., LTD. | TRAUS ENDO | 06/29/2015 |
| K123582 | SAEYANG MICROTECH CO., LTD | ENDO A CLASS | 08/16/2013 |
| K213897 | Saeyang Microtech Co., Ltd. | Pro M Class | 09/19/2022 |
| K222548 | Shenzhen Perfect Medical Instruments Co., Ltd. | Endo Motor | 04/26/2023 |
| K242514 | Shenzhen Rogin Medical Co., Ltd. | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | 04/24/2025 |
| K051661 | SIRONA DENTAL SYSTEMS GMBH | IMPLANT HANDPIECES | 09/06/2005 |
| K052515 | SIRONA DENTAL SYSTEMS GMBH | SIROENDO | 03/31/2006 |
| K990739 | SYBRON DENTAL SPECIALTIES, INC. | QUANTEC-E ENDO SYSTEM | 05/26/1999 |
| K143445 | Tellos Medical AB | Tellos ISQ Buddy | 01/07/2016 |
| K090931 | W & H DENTALWERK BUERMOOS GMBH | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | 12/15/2009 |
| K100600 | W & H DENTALWERK BUERMOOS GMBH | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | 07/09/2010 |
| K201703 | W&H Dentalwerk Buermoos GmbH | PROXEO Twist Cordless Polishing System PL-40 H | 02/24/2021 |
| K063007 | WESTPORT MEDICAL, INC. | POWERTOME PERIOTOME | 10/17/2006 |
| K171377 | Young Dental Manufacturing Co 1, LLC | Young INFINITY Cordless Handpiece System | 08/20/2018 |
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