EKX · Handpiece, Direct Drive, Ac-Powered
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EKX |
|---|---|
| Device Name | Handpiece, Direct Drive, Ac-Powered |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
Classification Rationale
Class I.
Cleared Devices (89)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | Oct 16, 2025 | SESE |
| K251597 | InnerView System | Perimetrics, Inc. | Sep 18, 2025 | SESE |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | Aug 22, 2025 | SESE |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | Apr 24, 2025 | SESE |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | Mar 21, 2025 | SESE |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | Dec 20, 2024 | SESE |
| K222688 | The Trust | Genoss Co., Ltd. | Aug 9, 2024 | SESE |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | Jul 24, 2024 | SESE |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | Jul 9, 2024 | SESE |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | Nov 9, 2023 | SESE |
| K232657 | InnerView LC | Perimetrics, Inc. | Sep 1, 2023 | SESE |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | May 18, 2023 | SESE |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | Apr 26, 2023 | SESE |
| K210475 | EQ-M | Meta Systems Co., Ltd. | Sep 21, 2022 | SESE |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | Sep 19, 2022 | SESE |
| K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. | Jun 24, 2022 | SESE |
| K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. | Dec 17, 2021 | SESE |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | May 10, 2021 | SESE |
| K192649 | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. | Mar 12, 2021 | SESE |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | Feb 24, 2021 | SESE |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | Jan 29, 2021 | SESE |
| K191276 | Dental Electrical Motor iRoot Pro | Changzhou Bomedent Medical Technology Co.,Ltd | Jun 30, 2020 | SESE |
| K181888 | Osstell Beacon | Osstell AB | Aug 22, 2019 | SESE |
| K180682 | AeroPro Cordless Prophy System | Premier Dental Company Products | Feb 27, 2019 | SESE |
| K180953 | AnyCheck IMT-100 | Dms Co., Ltd. | Feb 20, 2019 | SESE |
| K173920 | LS OIL | J. Morita USA, Inc. | Oct 11, 2018 | SESE |
| K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | Aug 20, 2018 | SESE |
| K180527 | IS3 | Hiossen, Inc. | May 16, 2018 | SESE |
| K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | Sep 11, 2017 | SESE |
| K161500 | MEG-TORQ | Micro-Nx Co., Ltd. | Feb 22, 2017 | SESE |
| K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | Dentsply Sirona | Sep 27, 2016 | SESE |
| K153285 | EMS-200 | Meta Systems Co., Ltd. | Aug 12, 2016 | SESE |
| K143445 | Tellos ISQ Buddy | Tellos Medical AB | Jan 7, 2016 | SESE |
| K143411 | TRAUS ENDO | Saeshin Precision Co., Ltd. | Jun 29, 2015 | SESE |
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | Aseptico, Inc. | May 28, 2015 | SESE |
| K142358 | Osstell IDx | Osstell AB | Feb 19, 2015 | SESE |
| K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. | Dec 31, 2014 | SESE |
| K133298 | ENDO SMART | Meta Biomed, Inc. | Sep 19, 2014 | SESE |
| K132401 | MEGA ISQ | Osstell AB | Apr 9, 2014 | SESE |
| K131578 | IPROPHY MOBILE | Nakanishi, Inc. | Sep 12, 2013 | SESE |
| K123582 | ENDO A CLASS | Saeyang Microtech Co., Ltd. | Aug 16, 2013 | SESE |
| K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | J. Morita USA, Inc. | May 4, 2012 | SESE |
| K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 | Nakanishi, Inc. | Feb 15, 2012 | SESE |
| K111616 | E-CUBE | Saeshin Precision Co., Ltd. | Aug 19, 2011 | SESE |
| K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. | Jun 14, 2011 | SESE |
| K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | Dentsply International, Inc. | Jun 6, 2011 | SESE |
| K103399 | GENERAL DENISTRY MOTOR | Aseptico, Inc. | Feb 28, 2011 | SESE |
| K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | W&H Dentalwerk Buermoos GmbH | Jul 9, 2010 | SESE |
| K101612 | ZEN CORDLESS PROPHY SYSTEM | Discus Dental, LLC | Jun 30, 2010 | SESE |
| K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | Dentamerica | Jan 7, 2010 | SESE |
| K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | W&H Dentalwerk Buermoos GmbH | Dec 15, 2009 | SESE |
| K092614 | X-SMART EASY | Dentsply Interntional | Dec 2, 2009 | SESE |
| K091913 | HI TECH IMPLANT, HT PHYSIO IMPLANT | By Dental Srl | Oct 30, 2009 | SESE |
| K082325 | APEXUM ABLATOR | Apexum , Ltd. | Apr 21, 2009 | SESE |
| K082523 | OSSTELL ISQ IMPLANT STABILITY METER | Osstell AB | Sep 26, 2008 | SESE |
| K072213 | PERIMETRICS PERIOMETER | Perimetrics, Inc. | Aug 29, 2008 | SESE |
| K081191 | TCM ENDO 20 | NOUVAG AG | Aug 7, 2008 | SESE |
| K071190 | ROOT ZX II | J. Morita USA, Inc. | Aug 17, 2007 | SESE |
| K063007 | POWERTOME PERIOTOME | Westport Medical, Inc. | Oct 17, 2006 | SESE |
| K052515 | SIROENDO | Sirona Dental Systems GmbH | Mar 31, 2006 | SESE |
| K051661 | IMPLANT HANDPIECES | Sirona Dental Systems GmbH | Sep 6, 2005 | SESE |
| K050612 | LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE | Lightspeed Technology, Inc. | May 4, 2005 | SESE |
| K042822 | TCM ENDO V, MODEL 1534 | NOUVAG AG | Dec 22, 2004 | SESE |
| K041279 | IMPLANTEO IMPLANTOLOGY MOTOR | Anthogyr | Sep 23, 2004 | SESE |
| K033689 | OSSTELL MENTOR RFA | Integration Diagnostics, Ltd. | Feb 26, 2004 | SESE |
| K033597 | ATR 5000, LC 5000, IMPLANT SYSTEM | Advanced Technology Research (A.T.R.) S.R.L. | Nov 25, 2003 | SESE |
| K031204 | DENTAPORT ZX | J. Morita USA, Inc. | Aug 21, 2003 | SESE |
| K031540 | APEX ELECTRIC HANDPIECE SYSTEM | Lares Research, Inc. | Jun 30, 2003 | SESE |
| K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | Aseptico, Inc. | Mar 3, 2003 | SESE |
| K012944 | POWER DRIVE | Mediteam AB | Nov 20, 2001 | SESE |
| K003714 | OSSTELL RESONANCE FREQUENCY ANALYZER | Integration Diagnostics, Ltd. | Aug 9, 2001 | SESE |
| K993188 | ENDOSTEPPER 1 | Phytron- Elektronik GmbH | Sep 28, 1999 | SESE |
| K990739 | QUANTEC-E ENDO SYSTEM | Sybron Dental Specialties, Inc. | May 26, 1999 | SESE |
| K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Nsk Nakanishi, Inc. | Mar 24, 1999 | SESE |
| K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | Nsk Nakanishi, Inc. | Mar 19, 1999 | SESE |
| K983413 | MODEL MS-1 HANDPIECE | Parkell, Inc. | Dec 21, 1998 | SESE |
| K970339 | TRI AUTO ZX | J. Morita USA, Inc. | Jun 4, 1997 | SESE |
| K932600 | MODIFIED SITE POWER HANDPIECE II | Chiron Vision Corp. | Jan 25, 1994 | SESE |
| K915634 | FRESENIUS PD+ EXCHANGE DEVICE | Fresenius USA, Inc. | Jul 1, 1993 | SESE |
| K922077 | MODIFIED SITE POWER HANDPIECE | Chiron Vision Corp. | Jun 23, 1992 | SESE |
| K905071 | MX CYCLER | Dakmed, Inc. | May 28, 1991 | SESE |
| K872171 | PERIOTEST | Siemens Medical Solutions USA, Inc. | Jun 23, 1987 | SESE |
| K870797 | PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE | Safco Dental Supply | May 1, 1987 | SESE |
| K832063 | ROBIN CORDLESS HANDPIECE | Kaycor Intl., Ltd. | Aug 26, 1983 | SESE |
| K821739 | J. MORITA FLEX M-3 TORX HARDPIECE | Pacific Dental Corp. | Jun 25, 1982 | SESE |
| K813348 | YOSHIDA RIDO-F, MODEL LM-01 | Kaycor Intl., Ltd. | Jan 7, 1982 | SESE |
| K801687 | TORX MICRO-MOTOR LOW SPEED HANDPIECE | Pacific Dental Corp. | Aug 4, 1980 | SESE |
| K780646 | AIR-PWOERED COLDRILL | Medishield, Inc. | Apr 28, 1978 | SESE |
| K760724 | PERITONEAL DIALYSIS SYSTEM | Physio-Control Corp. | Nov 23, 1976 | SESE |
Top Applicants
- J. Morita USA, Inc. — 6 clearances
- Aseptico, Inc. — 5 clearances
- Osstell AB — 4 clearances
- W&H Dentalwerk Buermoos GmbH — 3 clearances
- Saeshin Precision Co., Ltd. — 3 clearances
