Handpiece, Direct Drive, Ac-Powered

FDA product code EKX · 84 cleared devices

Class 1 Dental

Regulation: 21 CFR 872.4200
Review panel: DE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-11-23 – 2026-09-08

EKX 2026-09-08

Reusable SmartPeg

Applicant Osstell AB

K number K261987

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EKX 2025-10-16

Alpha Endo Handpiece (Alpha Endo)

Applicant SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

K number K252223

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EKX 2025-09-18

InnerView System

Applicant Perimetrics, Inc.

K number K251597

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EKX 2025-08-22

EnDrive (EnDriveUS)

Applicant Advanced Technology Research (A.T.R.) S.R.L.

K number K243692

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EKX 2025-04-24

Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)

Applicant Shenzhen Rogin Medical Co., Ltd.

K number K242514

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EKX 2025-03-21

ChecQ (AC100)

Applicant Dentis Co., Ltd.

K number K241065

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EKX 2024-12-20

HPR Cordless Hygiene Handpiece

Applicant Handpiece Headquarters

K number K243911

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EKX 2024-08-09

The Trust

Applicant Genoss Co., Ltd.

K number K222688

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EKX 2024-07-24

X-Smart Pro; X-Smart Pro+

Applicant Dentsply Sirona, Inc.

K number K233865

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EKX 2024-07-09

EM-07 Cordless Endo Motor

Applicant Forum Engineering Technologies (96) , Ltd.

K number K232551

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EKX 2023-11-09

Dental Handpiece, Wireless Endodontic Handpiece, endoit

Applicant Micro-Nx Co., Ltd.

K number K232810

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EKX 2023-09-01

InnerView LC

Applicant Perimetrics, Inc.

K number K232657

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EKX 2023-05-18

Endo Motor

Applicant Foshan Coxo Medical Instrument Co., Ltd.

K number K220829

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EKX 2023-04-26

Endo Motor

Applicant Shenzhen Perfect Medical Instruments Co., Ltd.

K number K222548

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EKX 2022-09-21

EQ-M

Applicant Meta Systems Co., Ltd.

K number K210475

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EKX 2022-09-19

Pro M Class

Applicant Saeyang Microtech Co., Ltd.

K number K213897

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EKX 2022-06-24

TRAUS ENDO

Applicant Saeshin Precision Co., Ltd.

K number K212043

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EKX 2021-12-17

Cordless Prophy System, Model: i-Polish

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K number K211531

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EKX 2021-05-10

Endo Motor

Applicant Guilin Woodpecker Medical Instrument Co., Ltd.

K number K203320

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EKX 2021-03-12

Endo Motor

Applicant Foshan Cicada Dental Instrument Co, Ltd.

K number K192649

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EKX 2021-02-24

PROXEO Twist Cordless Polishing System PL-40 H

Applicant W&H Dentalwerk Buermoos GmbH

K number K201703

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EKX 2021-01-29

E-connect S Endo Motor with built-in Apex Locator

Applicant Changzhou Sifary Medical Technology Co., Ltd.

K number K201993

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EKX 2020-06-30

Dental Electrical Motor iRoot Pro

Applicant Changzhou Bomedent Medical Technology Co.,Ltd

K number K191276

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EKX 2019-08-22

Osstell Beacon

Applicant Osstell AB

K number K181888

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EKX 2019-02-27

AeroPro Cordless Prophy System

Applicant Premier Dental Company Products

K number K180682

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EKX 2019-02-20

AnyCheck IMT-100

Applicant Dms Co., Ltd.

K number K180953

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EKX 2018-10-11

LS OIL

Applicant J. Morita USA, Inc.

K number K173920

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EKX 2018-08-20

Young INFINITY Cordless Handpiece System

Applicant Young Dental Manufacturing Co. 1, LLC

K number K171377

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EKX 2018-05-16

IS3

Applicant Hiossen, Inc.

K number K180527

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EKX 2017-09-11

Tri Auto ZX2

Applicant J. Morita USA, Inc.

K number K170275

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EKX 2017-02-22

MEG-TORQ

Applicant Micro-Nx Co., Ltd.

K number K161500

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EKX 2016-09-27

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology

Applicant Dentsply Sirona

K number K160825

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EKX 2016-08-12

EMS-200

Applicant Meta Systems Co., Ltd.

K number K153285

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EKX 2016-01-07

Tellos ISQ Buddy

Applicant Tellos Medical AB

K number K143445

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EKX 2013-09-12

IPROPHY MOBILE

Applicant Nakanishi, Inc.

K number K131578

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EKX 2013-08-16

ENDO A CLASS

Applicant Saeyang Microtech Co., Ltd.

K number K123582

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EKX 2012-05-04

TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE

Applicant J. Morita USA, Inc.

K number K112665

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EKX 2012-02-15

CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900

Applicant Nakanishi, Inc.

K number K110278

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EKX 2011-08-19

E-CUBE

Applicant Saeshin Precision Co., Ltd.

K number K111616

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EKX 2011-06-14

AEU-26L ELCTRONIC ENDODONTIC SYSTEM

Applicant Aseptico, Inc.

K number K111078

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EKX 2011-06-06

MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM

Applicant Dentsply International, Inc.

K number K110753

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EKX 2011-02-28

GENERAL DENISTRY MOTOR

Applicant Aseptico, Inc.

K number K103399

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EKX 2010-07-09

PROSTHODONTIC SCREWDRIVER , MODEL IA-400

Applicant W&H Dentalwerk Buermoos GmbH

K number K100600

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EKX 2010-06-30

ZEN CORDLESS PROPHY SYSTEM

Applicant Discus Dental, LLC

K number K101612

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EKX 2010-01-07

ENDOMAX CORDLESS ENDODONTIC HANDPIECE

Applicant Dentamerica

K number K092833

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EKX 2009-12-15

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR

Applicant W&H Dentalwerk Buermoos GmbH

K number K090931

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EKX 2009-12-02

X-SMART EASY

Applicant Dentsply Interntional

K number K092614

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EKX 2009-10-30

HI TECH IMPLANT, HT PHYSIO IMPLANT

Applicant By Dental Srl

K number K091913

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EKX 2009-04-21

APEXUM ABLATOR

Applicant Apexum , Ltd.

K number K082325

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EKX 2008-09-26

OSSTELL ISQ IMPLANT STABILITY METER

Applicant Osstell AB

K number K082523

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EKX 2008-08-29

PERIMETRICS PERIOMETER

Applicant Perimetrics, Inc.

K number K072213

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EKX 2008-08-07

TCM ENDO 20

Applicant NOUVAG AG

K number K081191

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EKX 2007-08-17

ROOT ZX II

Applicant J. Morita USA, Inc.

K number K071190

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EKX 2006-10-17

POWERTOME PERIOTOME

Applicant Westport Medical, Inc.

K number K063007

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EKX 2006-03-31

SIROENDO

Applicant Sirona Dental Systems GmbH

K number K052515

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EKX 2005-09-06

IMPLANT HANDPIECES

Applicant Sirona Dental Systems GmbH

K number K051661

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EKX 2005-05-04

LIGHTSPEED CORDLESS ENDODONTIC HANDPIECE

Applicant Lightspeed Technology, Inc.

K number K050612

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EKX 2004-12-22

TCM ENDO V, MODEL 1534

Applicant NOUVAG AG

K number K042822

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EKX 2004-09-23

IMPLANTEO IMPLANTOLOGY MOTOR

Applicant Anthogyr

K number K041279

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EKX 2004-02-26

OSSTELL MENTOR RFA

Applicant Integration Diagnostics, Ltd.

K number K033689

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EKX 2003-11-25

ATR 5000, LC 5000, IMPLANT SYSTEM

Applicant Advanced Technology Research (A.T.R.) S.R.L.

K number K033597

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EKX 2003-08-21

DENTAPORT ZX

Applicant J. Morita USA, Inc.

K number K031204

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EKX 2003-06-30

APEX ELECTRIC HANDPIECE SYSTEM

Applicant Lares Research, Inc.

K number K031540

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EKX 2003-03-03

ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925

Applicant Aseptico, Inc.

K number K030163

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EKX 2001-11-20

POWER DRIVE

Applicant Mediteam AB

K number K012944

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EKX 2001-08-09

OSSTELL RESONANCE FREQUENCY ANALYZER

Applicant Integration Diagnostics, Ltd.

K number K003714

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EKX 1999-09-28

ENDOSTEPPER 1

Applicant Phytron- Elektronik GmbH

K number K993188

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EKX 1999-05-26

QUANTEC-E ENDO SYSTEM

Applicant Sybron Dental Specialties, Inc.

K number K990739

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EKX 1999-03-24

PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)

Applicant Nsk Nakanishi, Inc.

K number K990682

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EKX 1999-03-19

PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE

Applicant Nsk Nakanishi, Inc.

K number K990646

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EKX 1998-12-21

MODEL MS-1 HANDPIECE

Applicant Parkell, Inc.

K number K983413

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EKX 1997-06-04

TRI AUTO ZX

Applicant J. Morita USA, Inc.

K number K970339

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EKX 1994-01-25

MODIFIED SITE POWER HANDPIECE II

Applicant Chiron Vision Corp.

K number K932600

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EKX 1993-07-01

FRESENIUS PD+ EXCHANGE DEVICE

Applicant Fresenius USA, Inc.

K number K915634

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EKX 1992-06-23

MODIFIED SITE POWER HANDPIECE

Applicant Chiron Vision Corp.

K number K922077

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EKX 1991-05-28

MX CYCLER

Applicant Dakmed, Inc.

K number K905071

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EKX 1987-06-23

PERIOTEST

Applicant Siemens Medical Solutions USA, Inc.

K number K872171

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EKX 1987-05-01

PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE

Applicant Safco Dental Supply

K number K870797

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EKX 1983-08-26

ROBIN CORDLESS HANDPIECE

Applicant Kaycor Intl., Ltd.

K number K832063

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EKX 1982-06-25

J. MORITA FLEX M-3 TORX HARDPIECE

Applicant Pacific Dental Corp.

K number K821739

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EKX 1982-01-07

YOSHIDA RIDO-F, MODEL LM-01

Applicant Kaycor Intl., Ltd.

K number K813348

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EKX 1980-08-04

TORX MICRO-MOTOR LOW SPEED HANDPIECE

Applicant Pacific Dental Corp.

K number K801687

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EKX 1978-04-28

AIR-PWOERED COLDRILL

Applicant Medishield, Inc.

K number K780646

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EKX 1976-11-23

PERITONEAL DIALYSIS SYSTEM

Applicant Physio-Control Corp.

K number K760724

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