Surgical devices · 21 CFR 872 Subpart E
Ac-Powered Direct Drive Handpiece
FDA device type “Handpiece, Direct Drive, Ac-Powered”.
- Companies listing it
- 8441 makers
- Brands and models
- 468
- 510(k) clearances
- 9018 in five years
- FDA name
- Handpiece, Direct Drive, Ac-Powered
510(k) clearances per year, 1976–2026
Companies that list EKX
84 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | ChecQ (AC100) | 37 | 2026 |
| Nakanishi, Inc. | Japan | Maker | ARK-F4R · ARS-F4R · EM10M · EM10M2 · +51 | 37 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | ACE · Cordless Prophy System · E-COM, Endo Radar · Endo Motor, Ai- Motor, Endo Radar Plus · +12 | 12 | 2025 |
| GENOSS Co., Ltd. | South Korea | Maker | TT-1 | 23 | 2025 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Endo Motor; C-Smart-I Pro, C-SMART-I PILOT, C-Smart-mini, C-SMART-MINI AP | 6 | 2025 |
| Meta Biomed Co, Ltd | United States | Maker | EQ-M | 24 | 2024 |
| MICRO-NX Co., Ltd. | South Korea | Maker | Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model: EH-C500) · Dental Torque Driver for Implant Surgery (Model: MEG-TORQ) · Dental Torque Driver for Implant Surgery (Model: OSM-TORQ) · Dental Torque Driver for Implant Surgery (Model: TD-C60) | 7 | 2025 |
| Premier Dental Products Company | United States | Maker | AeroPro Cordless Prophy System | 28 | 2026 |
| Young Innovations Inc | United States | Maker | Young Infinity Cordless Handpiece System | 23 | 2025 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | E-CUBE | 16 | 2026 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | E-Connect S Endo Motor With Built-In Apex Locator · Z-Evo | 4 | 2026 |
| Handpiece Headquarters | United States | Maker | HPR Cordless Hygiene Handpiece | 7 | 2024 |
| Perimetrics, Inc | United States | Maker | InnerView System | 3 | 2025 |
| Coltene/Whaledent AG | Switzerland | Maker | CanalPro CL · CanalPro CL2 · CanalPro X-Move | 45 | 2022 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Osstell AB | Sweden | Maker | Mega ISQ II · NeoTell · Osstell Beacon · Osstell Classic · +24 | 5 | 2026 |
| Foshan Cicada Dental Instrument Co, Ltd. | China | Maker | Endo Motor, Root Canal Motor Device T-Fine I, II, III, IV, V, VK-Endo I, II, III | 4 | 2022 |
| KaVo Dental GmbH | Germany | Maker | 101.8748 - ELECTROtorque plus · 102.5015 - ELECTROtorque plus (Set) · 103.3490 - ELECTROtorque TLC 4893 · 103.5622 - INTRAmatic LUX 702 KL · +3 | 2 | 2021 |
| ChangZhou BoMedent Medical Technology Co., Ltd | China | Maker | Dental Electrical Motor iRoot Pro | 2 | 2022 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | 1 | 2025 |
| Shenzhen Superline Technology Co Ltd | China | Maker | Endo Handpiece, Endo Motor,Dental handpiece, Fliex | 1 | 2025 |
| Denjoy Dental Co., Ltd. | China | Maker | Integrated Endo System (Meet Endo-II) · JAS Activator · JAS Activator Ultrasonic Tips · JAS Charging Unit · +7 | 1 | 2025 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | China | Maker | Endo Motor | 1 | 2023 |
| Forum Engineering Technologies (96) Ltd. | Israel | Maker | EM-07 Cordless Endo Motor · Statera vi · X-Smart Go | 1 | 2024 |
| Aseptico, Inc. | United States | Maker | AE-10 - TUBING LRG 5FT/MIN FOR AE-20 SILICONE 62ID X .125OD · AE-2 - FTN BARB 1/16 Y PLASTIC · AE-20 - TUBING PUMP SET ASEPTICO · AE-20Y - TUBING PUMP SET AEU-707Y YOSHIDA · +136 | 17 | 2015 |
| Monitex Industrial Co., Ltd. | Taiwan | Maker | HPR Cordless Hygiene Handpiece | 9 | 2017 |
| Asi Medical, Inc. | United States | Maker | Advanced Dental System · Advanced Endodontic System · Triton Dental System | 5 | 2013 |
| Osada Electric Co., Ltd. | Japan | Maker | OSADA HANDPIECE, DIRECT DRIVE, AC-POWERED | 2 | 1994 |
| Angstrom Mfg., Inc. | United States | Maker | Prophy Angle | 2 | 2011 |
| DMS Co., Ltd. | South Korea | Maker | AnyCheck IMT-100 | 1 | 2019 |
| Schlumbohm GmbH & Co. KG | Germany | Maker | EndoPilot | 1 | 2021 |
| Beyes Dental Inc | Canada | Maker | Endo motor, G1;G2;G3;G4;G5 | — | — |
| J. Morita MFG Corp. | Japan | Maker | EndoSync · EndoSync Plus · LS OIL · Root ZX II · +2 | — | — |
| Sanko Electronics Corporation | Japan | Maker | EMD120V1 · EMD120VS · iProphy mobile complete set · iProphy mobile Motor · +1 | — | — |
| Integration Diagnostics Sweden AB | Sweden | Maker | IS3 · IS4 · Locking screwdriver · MDI MulTipeg · +7 | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| SAEYANG Co.,Ltd 韩国（株）世洋 | South Korea | Maker | CanalPro CL2 · Endo A Class · PRO M CLASS | — | — |
| Force Engineering Co.ltd | Japan | Maker | EM13M | — | — |
| Jung Chen Technology Co., Ltd | China | Maker | AeroPro Cordless Prophy System | — | — |
| Nextmed srls | Italy | Maker | EnDrive | — | — |
| Nobel Biocare Services AG | Switzerland | Contract manufacturer | Beacon · Smart Pegs Type 1-115 | 94 | 2026 |
| Sybron Dental Specialties | United States | Contract manufacturer | elements Connect · elements motor · EndoTouch TC2 · M4 TC2 Handpiece | 203 | 2026 |
| Ultradent Products, Inc. | United States | Contract manufacturer | Ultrapro Tx Cordless Prophy Motor Kit | 95 | 2026 |
| Park Dental Research Corp | United States | Contract manufacturer | — | 8 | 2026 |
| Imagine Milling Technologies, LLC | United States | Contract manufacturer | Penguin RFA MulTipegs | 4 | 2026 |
| Satelec - Acteon Group | United States | Manufacturer | EndoCenter · I-SURGE + · Scaler Ultra Sonic | 18 | 2024 |
| Neobiotech Co., Ltd. | South Korea | Foreign exporter | AnyCheck IMT-100 | 17 | 2024 |
| Dentalez, Inc. | United States | Manufacturer | iStar Cordless Prophy Handpiece | 9 | 2026 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| SIC invent AG | Switzerland | Foreign exporter | — | 5 | 2026 |
| A-dec, Inc. | United States | Manufacturer | Midwest Electric Motor | 68 | 2022 |
| Essential Dental Systems, Inc. | United States | Repacker / relabeler | Endo CSV Hand Piece | 15 | 2023 |
| DIO Corporation | South Korea | Foreign exporter | DIO IDx | 14 | 2023 |
| Neoss AB | Sweden | Foreign exporter | — | 10 | 2022 |
| NuSmile, Ltd. | United States | Manufacturer | Avalon Biomed by ZARC Z-Evo | 2 | 2026 |
| Bicon, LLC | United States | Manufacturer | AEU-26BIC | 18 | 2015 |
| SWEDEN & MARTINA S.p.A. | Italy | Contract manufacturer | DENTAL HANDPIECE | 6 | 2019 |
| Dentamerica | United States | Repacker / relabeler | — | 4 | 2010 |
| COLTENE Holding AG | Switzerland | Contract manufacturer | CanalPro X-Move | 1 | 2003 |
| Gebr. Brasseler GmbH & Co. KG | Germany | Contract manufacturer | EndoPilot² · EnDrive | 1 | 2007 |
| Sweden & Martina INC | United States | Lister | DENTAL HANDPIECE | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Endo Motor · Handpiece, direct drive, ac-powered | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Handpiece, direct drive, ac-powered · Patterson Apex Locator · Patterson Handpiece · Ultraviolet Activator | — | — |
| Swann Morton Limited | United Kingdom | Contract sterilizer | 100350 SmartPeg Type 4 · 100353 SmartPeg Type 1 · 100355 SmartPeg Type 2 · 100357 SmartPeg Type 3 · +101 | — | — |
| HSG-S Corp | United States | Manufacturer | EdgeApex · EdgeApex HP · EdgeEndo® · EdgeFlow | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | MOTOPEX | — | — |
| GoldenDent | United States | Repacker / relabeler | Endo Motor | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Z-EVO | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | — | — | — |
| Medline Industries, LP | United States | Contract sterilizer | — | — | — |
| Onvet Medical Canada Inc. | Canada | Manufacturer | Endo Motors | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Motopex | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | TOYO MEDICAL CO | — | — |
| HANSAMED LIMITED dba CITAGENIX | Canada | Foreign exporter | Penguin RFA | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | Handpiece | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | — | — | — |
| Enova Illumination Inc. | United States | Lister | Endo Motor | — | — |
| Well Medical | South Korea | Foreign exporter | AUTOTORQ-35 | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Riverside Medical Packaging Company Ltd | United Kingdom | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 8 Sep 2026 | K261987 | Reusable SmartPeg | Osstell AB |
| 16 Oct 2025 | K252223 | Alpha Endo Handpiece (Alpha Endo) | Shenzhen Superline Technology Co Ltd |
| 18 Sep 2025 | K251597 | InnerView System | Perimetrics, Inc |
| 22 Aug 2025 | K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. |
| 24 Apr 2025 | K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. |
| 21 Mar 2025 | K241065 | ChecQ (AC100) | Dentis Co., Ltd. |
| 20 Dec 2024 | K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters |
| 9 Aug 2024 | K222688 | The Trust | GENOSS Co., Ltd. |
| 24 Jul 2024 | K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. |
| 9 Jul 2024 | K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) Ltd. |
| 9 Nov 2023 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | MICRO-NX Co., Ltd. |
| 1 Sep 2023 | K232657 | InnerView LC | Perimetrics, Inc |
| 18 May 2023 | K220829 | Endo Motor | Foshan COXO Medical Instrument Co., Ltd. |
| 26 Apr 2023 | K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. |
| 21 Sep 2022 | K210475 | EQ-M | Meta Systems Co., Ltd. |
| 19 Sep 2022 | K213897 | Pro M Class | Saeyang Microtech Co., Ltd. |
| 24 Jun 2022 | K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. |
| 17 Dec 2021 | K211531 | Cordless Prophy System, Model: i-Polish | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. |
| 12 Mar 2021 | K192649 | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. |
| 24 Feb 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH |
| 29 Jan 2021 | K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. |
| 30 Jun 2020 | K191276 | Dental Electrical Motor iRoot Pro | ChangZhou BoMedent Medical Technology Co., Ltd |
| 22 Aug 2019 | K181888 | Osstell Beacon | Osstell AB |
| 27 Feb 2019 | K180682 | AeroPro Cordless Prophy System | Premier Dental Company Products |
| 20 Feb 2019 | K180953 | AnyCheck IMT-100 | DMS Co., Ltd. |
| 11 Oct 2018 | K173920 | LS OIL | J. Morita USA, Inc. |
| 20 Aug 2018 | K171377 | Young INFINITY Cordless Handpiece System | Young Innovations Inc |
| 16 May 2018 | K180527 | IS3 | Hiossen Inc. |
| 11 Sep 2017 | K170275 | Tri Auto ZX2 | J. Morita USA, Inc. |
| 22 Feb 2017 | K161500 | MEG-TORQ | MICRO-NX Co., Ltd. |
| 27 Sep 2016 | K160825 | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology | Dentsply Sirona, Inc. |
| 12 Aug 2016 | K153285 | EMS-200 | Meta Systems Co., Ltd. |
| 7 Jan 2016 | K143445 | Tellos ISQ Buddy | Tellos Medical AB |
| 29 Jun 2015 | K143411 | TRAUS ENDO | Saeshin Precision Co., Ltd. |
| 28 May 2015 | K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | Aseptico, Inc. |
| 19 Feb 2015 | K142358 | Osstell IDx | Osstell AB |
| 31 Dec 2014 | K142124 | AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM | Aseptico, Inc. |
| 19 Sep 2014 | K133298 | ENDO SMART | Meta Biomed Co, Ltd |
| 9 Apr 2014 | K132401 | MEGA ISQ | Osstell AB |
| 12 Sep 2013 | K131578 | IPROPHY MOBILE | Nakanishi, Inc. |
| 16 Aug 2013 | K123582 | ENDO A CLASS | Saeyang Microtech Co., Ltd. |
| 4 May 2012 | K112665 | TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE | J. Morita USA, Inc. |
| 15 Feb 2012 | K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900 | Nakanishi, Inc. |
| 19 Aug 2011 | K111616 | E-CUBE | Saeshin Precision Co., Ltd. |
| 14 Jun 2011 | K111078 | AEU-26L ELCTRONIC ENDODONTIC SYSTEM | Aseptico, Inc. |
| 6 Jun 2011 | K110753 | MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM | Dentsply International, Inc. |
| 28 Feb 2011 | K103399 | GENERAL DENISTRY MOTOR | Aseptico, Inc. |
| 9 Jul 2010 | K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | W&H Dentalwerk Buermoos GmbH |
| 30 Jun 2010 | K101612 | ZEN CORDLESS PROPHY SYSTEM | Philips Medical Systems International BV |
| 7 Jan 2010 | K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | Dentamerica |
| 15 Dec 2009 | K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | W&H Dentalwerk Buermoos GmbH |
| 2 Dec 2009 | K092614 | X-SMART EASY | Dentsply Interntional |
| 30 Oct 2009 | K091913 | HI TECH IMPLANT, HT PHYSIO IMPLANT | By Dental Srl |
| 21 Apr 2009 | K082325 | APEXUM ABLATOR | Apexum , Ltd. |
| 26 Sep 2008 | K082523 | OSSTELL ISQ IMPLANT STABILITY METER | Osstell AB |
| 29 Aug 2008 | K072213 | PERIMETRICS PERIOMETER | Perimetrics, Inc |
| 7 Aug 2008 | K081191 | TCM ENDO 20 | Nouvag AG |
| 17 Aug 2007 | K071190 | ROOT ZX II | J. Morita USA, Inc. |
| 17 Oct 2006 | K063007 | POWERTOME PERIOTOME | Westport Medical, Inc. |
| 31 Mar 2006 | K052515 | SIROENDO | Dentsply Sirona, Inc. |
| 6 Sep 2005 | K051661 | IMPLANT HANDPIECES | Dentsply Sirona, Inc. |
| 4 May 2005 | K050612 | LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE | Lightspeed Technology, Inc. |
| 22 Dec 2004 | K042822 | TCM ENDO V, MODEL 1534 | Nouvag AG |
| 23 Sep 2004 | K041279 | IMPLANTEO IMPLANTOLOGY MOTOR | Institut Straumann AG |
| 26 Feb 2004 | K033689 | OSSTELL MENTOR RFA | Integration Diagnostics, Ltd. |
| 25 Nov 2003 | K033597 | ATR 5000, LC 5000, IMPLANT SYSTEM | Advanced Technology Research (A.T.R.) S.R.L. |
| 21 Aug 2003 | K031204 | DENTAPORT ZX | J. Morita USA, Inc. |
| 30 Jun 2003 | K031540 | APEX ELECTRIC HANDPIECE SYSTEM | Lares Research |
| 3 Mar 2003 | K030163 | ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 | Aseptico, Inc. |
| 20 Nov 2001 | K012944 | POWER DRIVE | Mediteam AB |
| 9 Aug 2001 | K003714 | OSSTELL RESONANCE FREQUENCY ANALYZER | Integration Diagnostics, Ltd. |
| 28 Sep 1999 | K993188 | ENDOSTEPPER 1 | Phytron- Elektronik GmbH |
| 26 May 1999 | K990739 | QUANTEC-E ENDO SYSTEM | Sybron Dental Specialties |
| 24 Mar 1999 | K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Nsk Nakanishi, Inc. |
| 19 Mar 1999 | K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | Nsk Nakanishi, Inc. |
| 21 Dec 1998 | K983413 | MODEL MS-1 HANDPIECE | Parkell, Inc |
| 4 Jun 1997 | K970339 | TRI AUTO ZX | J. Morita USA, Inc. |
| 25 Jan 1994 | K932600 | MODIFIED SITE POWER HANDPIECE II | Chiron Vision Corp. |
| 1 Jul 1993 | K915634 | FRESENIUS PD+ EXCHANGE DEVICE | Fresenius USA, Inc. |
| 23 Jun 1992 | K922077 | MODIFIED SITE POWER HANDPIECE | Chiron Vision Corp. |
| 28 May 1991 | K905071 | MX CYCLER | Dakmed, Inc. |
| 23 Jun 1987 | K872171 | PERIOTEST | Siemens Medical Solutions USA, Inc. |
| 1 May 1987 | K870797 | PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE | Safco Dental Supply |
| 26 Aug 1983 | K832063 | ROBIN CORDLESS HANDPIECE | Kaycor Intl., Ltd. |
| 25 Jun 1982 | K821739 | J. MORITA FLEX M-3 TORX HARDPIECE | Pacific Dental Corp. |
| 7 Jan 1982 | K813348 | YOSHIDA RIDO-F, MODEL LM-01 | Kaycor Intl., Ltd. |
| 4 Aug 1980 | K801687 | TORX MICRO-MOTOR LOW SPEED HANDPIECE | Pacific Dental Corp. |
| 28 Apr 1978 | K780646 | AIR-PWOERED COLDRILL | Medishield, Inc. |
| 23 Nov 1976 | K760724 | PERITONEAL DIALYSIS SYSTEM | Physio-Control Corp. |
Official records: FDA product classification for EKX · 21 CFR 872.4200.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026