Product Code: EKX FDA class 1 21 CFR 872.4200

Handpiece, Direct Drive, Ac-Powered

Dental

The AC-Powered Direct Drive Dental Handpiece is an electrically powered rotary instrument that directly drives a cutting bur or attachment without a belt or air turbine, offering precise speed control for restorative, surgical, and laboratory dental procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EKX, regulated under 21 CFR 872.4200 in the Dental (DE) specialty. This device is eligible for third-party review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code EKX in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: EKX
Device Class: FDA class 1
Regulation Number: 872.4200
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 89 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252223	Alpha Endo Handpiece (Alpha Endo)	Oct 16, 2025	Substantially Equivalent	SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
K251597	InnerView System	Sep 18, 2025	Substantially Equivalent	Perimetrics, Inc.
K243692	EnDrive (EnDriveUS)	Aug 22, 2025	Substantially Equivalent	Advanced Technology Research (A.T.R.) S.R.L.
K242514	Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)	Apr 24, 2025	Substantially Equivalent	Shenzhen Rogin Medical Co., Ltd.
K241065	ChecQ (AC100)	Mar 21, 2025	Substantially Equivalent	Dentis Co., Ltd.
K243911	HPR Cordless Hygiene Handpiece	Dec 20, 2024	Substantially Equivalent	Handpiece Headquarters
K222688	The Trust	Aug 09, 2024	Substantially Equivalent	Genoss Co., Ltd.
K233865	X-Smart Pro; X-Smart Pro+	Jul 24, 2024	Substantially Equivalent	Dentsply Sirona, Inc.
K232551	EM-07 Cordless Endo Motor	Jul 09, 2024	Substantially Equivalent	Forum Engineering Technologies (96) , Ltd.
K232810	Dental Handpiece, Wireless Endodontic Handpiece, endoit	Nov 09, 2023	Substantially Equivalent	Micro-Nx Co., Ltd.
K232657	InnerView LC	Sep 01, 2023	Substantially Equivalent	Perimetrics, Inc.
K220829	Endo Motor	May 18, 2023	Substantially Equivalent	Foshan Coxo Medical Instrument Co., Ltd.
K222548	Endo Motor	Apr 26, 2023	Substantially Equivalent	Shenzhen Perfect Medical Instruments Co., Ltd.
K210475	EQ-M	Sep 21, 2022	Substantially Equivalent	Meta Systems Co., Ltd.
K213897	Pro M Class	Sep 19, 2022	Substantially Equivalent	Saeyang Microtech Co., Ltd.
K212043	TRAUS ENDO	Jun 24, 2022	Substantially Equivalent	Saeshin Precision Co., Ltd.
K211531	Cordless Prophy System, Model: i-Polish	Dec 17, 2021	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K203320	Endo Motor	May 10, 2021	Substantially Equivalent	Guilin Woodpecker Medical Instrument Co., Ltd.
K192649	Endo Motor	Mar 12, 2021	Substantially Equivalent	Foshan Cicada Dental Instrument Co, Ltd.
K201703	PROXEO Twist Cordless Polishing System PL-40 H	Feb 24, 2021	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K201993	E-connect S Endo Motor with built-in Apex Locator	Jan 29, 2021	Substantially Equivalent	Changzhou Sifary Medical Technology Co., Ltd.
K191276	Dental Electrical Motor iRoot Pro	Jun 30, 2020	Substantially Equivalent	Changzhou Bomedent Medical Technology Co.,Ltd
K181888	Osstell Beacon	Aug 22, 2019	Substantially Equivalent	Osstell AB
K180682	AeroPro Cordless Prophy System	Feb 27, 2019	Substantially Equivalent	Premier Dental Company Products
K180953	AnyCheck IMT-100	Feb 20, 2019	Substantially Equivalent	Dms Co., Ltd.
K173920	LS OIL	Oct 11, 2018	Substantially Equivalent	J. Morita USA, Inc.
K171377	Young INFINITY Cordless Handpiece System	Aug 20, 2018	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K180527	IS3	May 16, 2018	Substantially Equivalent	Hiossen, Inc.
K170275	Tri Auto ZX2	Sep 11, 2017	Substantially Equivalent	J. Morita USA, Inc.
K161500	MEG-TORQ	Feb 22, 2017	Substantially Equivalent	Micro-Nx Co., Ltd.
K160825	MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology	Sep 27, 2016	Substantially Equivalent	Dentsply Sirona
K153285	EMS-200	Aug 12, 2016	Substantially Equivalent	Meta Systems Co., Ltd.
K143445	Tellos ISQ Buddy	Jan 07, 2016	Substantially Equivalent	Tellos Medical AB
K143411	TRAUS ENDO	Jun 29, 2015	Substantially Equivalent	Saeshin Precision Co., Ltd.
K150129	AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)	May 28, 2015	Substantially Equivalent	Aseptico, Inc.
K142358	Osstell IDx	Feb 19, 2015	Substantially Equivalent	Osstell AB
K142124	AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM	Dec 31, 2014	Substantially Equivalent	Aseptico, Inc.
K133298	ENDO SMART	Sep 19, 2014	Substantially Equivalent	Meta Biomed, Inc.
K132401	MEGA ISQ	Apr 09, 2014	Substantially Equivalent	Osstell AB
K131578	IPROPHY MOBILE	Sep 12, 2013	Substantially Equivalent	Nakanishi, Inc.
K123582	ENDO A CLASS	Aug 16, 2013	Substantially Equivalent	Saeyang Microtech Co., Ltd.
K112665	TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE	May 04, 2012	Substantially Equivalent	J. Morita USA, Inc.
K110278	CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900	Feb 15, 2012	Substantially Equivalent	Nakanishi, Inc.
K111616	E-CUBE	Aug 19, 2011	Substantially Equivalent	Saeshin Precision Co., Ltd.
K111078	AEU-26L ELCTRONIC ENDODONTIC SYSTEM	Jun 14, 2011	Substantially Equivalent	Aseptico, Inc.
K110753	MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM	Jun 06, 2011	Substantially Equivalent	Dentsply International, Inc.
K103399	GENERAL DENISTRY MOTOR	Feb 28, 2011	Substantially Equivalent	Aseptico, Inc.
K100600	PROSTHODONTIC SCREWDRIVER , MODEL IA-400	Jul 09, 2010	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K101612	ZEN CORDLESS PROPHY SYSTEM	Jun 30, 2010	Substantially Equivalent	Discus Dental, LLC
K092833	ENDOMAX CORDLESS ENDODONTIC HANDPIECE	Jan 07, 2010	Substantially Equivalent	Dentamerica
K090931	CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR	Dec 15, 2009	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K092614	X-SMART EASY	Dec 02, 2009	Substantially Equivalent	Dentsply Interntional
K091913	HI TECH IMPLANT, HT PHYSIO IMPLANT	Oct 30, 2009	Substantially Equivalent	By Dental Srl
K082325	APEXUM ABLATOR	Apr 21, 2009	Substantially Equivalent	Apexum , Ltd.
K082523	OSSTELL ISQ IMPLANT STABILITY METER	Sep 26, 2008	Substantially Equivalent	Osstell AB
K072213	PERIMETRICS PERIOMETER	Aug 29, 2008	Substantially Equivalent	Perimetrics, Inc.
K081191	TCM ENDO 20	Aug 07, 2008	Substantially Equivalent	NOUVAG AG
K071190	ROOT ZX II	Aug 17, 2007	Substantially Equivalent	J. Morita USA, Inc.
K063007	POWERTOME PERIOTOME	Oct 17, 2006	Substantially Equivalent	Westport Medical, Inc.
K052515	SIROENDO	Mar 31, 2006	Substantially Equivalent	Sirona Dental Systems GmbH
K051661	IMPLANT HANDPIECES	Sep 06, 2005	Substantially Equivalent	Sirona Dental Systems GmbH
K050612	LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE	May 04, 2005	Substantially Equivalent	Lightspeed Technology, Inc.
K042822	TCM ENDO V, MODEL 1534	Dec 22, 2004	Substantially Equivalent	NOUVAG AG
K041279	IMPLANTEO IMPLANTOLOGY MOTOR	Sep 23, 2004	Substantially Equivalent	Anthogyr
K033689	OSSTELL MENTOR RFA	Feb 26, 2004	Substantially Equivalent	Integration Diagnostics, Ltd.
K033597	ATR 5000, LC 5000, IMPLANT SYSTEM	Nov 25, 2003	Substantially Equivalent	Advanced Technology Research (A.T.R.) S.R.L.
K031204	DENTAPORT ZX	Aug 21, 2003	Substantially Equivalent	J. Morita USA, Inc.
K031540	APEX ELECTRIC HANDPIECE SYSTEM	Jun 30, 2003	Substantially Equivalent	Lares Research, Inc.
K030163	ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925	Mar 03, 2003	Substantially Equivalent	Aseptico, Inc.
K012944	POWER DRIVE	Nov 20, 2001	Substantially Equivalent	Mediteam AB
K003714	OSSTELL RESONANCE FREQUENCY ANALYZER	Aug 09, 2001	Substantially Equivalent	Integration Diagnostics, Ltd.
K993188	ENDOSTEPPER 1	Sep 28, 1999	Substantially Equivalent	Phytron- Elektronik GmbH
K990739	QUANTEC-E ENDO SYSTEM	May 26, 1999	Substantially Equivalent	Sybron Dental Specialties, Inc.
K990682	PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)	Mar 24, 1999	Substantially Equivalent	Nsk Nakanishi, Inc.
K990646	PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE	Mar 19, 1999	Substantially Equivalent	Nsk Nakanishi, Inc.
K983413	MODEL MS-1 HANDPIECE	Dec 21, 1998	Substantially Equivalent	Parkell, Inc.
K970339	TRI AUTO ZX	Jun 04, 1997	Substantially Equivalent	J. Morita USA, Inc.
K932600	MODIFIED SITE POWER HANDPIECE II	Jan 25, 1994	Substantially Equivalent	Chiron Vision Corp.
K915634	FRESENIUS PD+ EXCHANGE DEVICE	Jul 01, 1993	Substantially Equivalent	Fresenius USA, Inc.
K922077	MODIFIED SITE POWER HANDPIECE	Jun 23, 1992	Substantially Equivalent	Chiron Vision Corp.
K905071	MX CYCLER	May 28, 1991	Substantially Equivalent	Dakmed, Inc.
K872171	PERIOTEST	Jun 23, 1987	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K870797	PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE	May 01, 1987	Substantially Equivalent	Safco Dental Supply
K832063	ROBIN CORDLESS HANDPIECE	Aug 26, 1983	Substantially Equivalent	Kaycor Intl., Ltd.
K821739	J. MORITA FLEX M-3 TORX HARDPIECE	Jun 25, 1982	Substantially Equivalent	Pacific Dental Corp.
K813348	YOSHIDA RIDO-F, MODEL LM-01	Jan 07, 1982	Substantially Equivalent	Kaycor Intl., Ltd.
K801687	TORX MICRO-MOTOR LOW SPEED HANDPIECE	Aug 04, 1980	Substantially Equivalent	Pacific Dental Corp.
K780646	AIR-PWOERED COLDRILL	Apr 28, 1978	Substantially Equivalent	Medishield, Inc.
K760724	PERITONEAL DIALYSIS SYSTEM	Nov 23, 1976	Substantially Equivalent	Physio-Control Corp.