EKX · Class I · 21 CFR 872.4200

FDA Product Code EKX: Handpiece, Direct Drive, Ac-powered

Leading manufacturers include J. Morita USA, Inc., Guilin Woodpecker Medical Instrument Co., Ltd. and Sirona Dental Systems GmbH.

89
Total
89
Cleared
183d
Avg days
1976
Since
Declining activity - 6 submissions in the last 2 years vs 9 in the prior period
Consistent review times: 176d avg (recent)

FDA 510(k) Cleared Handpiece, Direct Drive, Ac-powered Devices (Product Code EKX)

89 devices
1–24 of 89
Cleared Oct 16, 2025
Alpha Endo Handpiece (Alpha Endo)
K252223
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 92d
Cleared Sep 18, 2025
InnerView System
K251597
Perimetrics, Inc.
Dental · 114d
Cleared Aug 22, 2025
EnDrive (EnDriveUS)
K243692
Advanced Technology Research (A.T.R.) S.R.L.
Dental · 266d
Cleared Apr 24, 2025
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
K242514
Shenzhen Rogin Medical Co., Ltd.
Dental · 244d
Cleared Mar 21, 2025
ChecQ (AC100)
K241065
Dentis Co., Ltd.
Dental · 337d
Cleared Dec 20, 2024
HPR Cordless Hygiene Handpiece
K243911
Handpiece Headquarters
Dental · 1d
Cleared Aug 09, 2024
The Trust
K222688
Genoss Co., Ltd.
Dental · 703d
Cleared Jul 24, 2024
X-Smart Pro
K233865
Dentsply Sirona, Inc.
Dental · 231d
Cleared Jul 09, 2024
EM-07 Cordless Endo Motor
K232551
Forum Engineering Technologies (96) , Ltd.
Dental · 321d
Cleared Nov 09, 2023
Dental Handpiece, Wireless Endodontic Handpiece, endoit
K232810
Micro-Nx Co., Ltd.
Dental · 58d
Cleared Sep 01, 2023
InnerView LC
K232657
Perimetrics, Inc.
Dental · 1d
Cleared May 18, 2023
Endo Motor
K220829
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 422d
Cleared Apr 26, 2023
Endo Motor
K222548
Shenzhen Perfect Medical Instruments Co., Ltd.
Dental · 246d
Cleared Sep 21, 2022
EQ-M
K210475
Meta Systems Co., Ltd.
Dental · 581d
Cleared Sep 19, 2022
Pro M Class
K213897
Saeyang Microtech Co., Ltd.
Dental · 279d
Cleared Jun 24, 2022
TRAUS ENDO
K212043
Saeshin Precision Co., Ltd.
Dental · 359d
Cleared Dec 17, 2021
Cordless Prophy System, Model: i-Polish
K211531
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 214d
Cleared May 10, 2021
Endo Motor
K203320
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 179d
Cleared Mar 12, 2021
Endo Motor
K192649
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 535d
Cleared Feb 24, 2021
PROXEO Twist Cordless Polishing System PL-40 H
K201703
W&H Dentalwerk Buermoos GmbH
Dental · 247d
Cleared Jan 29, 2021
E-connect S Endo Motor with built-in Apex Locator
K201993
Changzhou Sifary Medical Technology Co., Ltd.
Dental · 196d
Cleared Jun 30, 2020
Dental Electrical Motor iRoot Pro
K191276
Changzhou Bomedent Medical Technology Co.,Ltd
Dental · 414d
Cleared Aug 22, 2019
Osstell Beacon
K181888
Osstell AB
Dental · 405d
Cleared Feb 27, 2019
AeroPro Cordless Prophy System
K180682
Premier Dental Company Products
Dental · 349d

About Product Code EKX - Regulatory Context

510(k) Submission Activity

89 total 510(k) submissions under product code EKX since 1976, with 89 receiving FDA clearance (average review time: 183 days).

Submission volume has declined in recent years - 6 submissions in the last 24 months compared to 9 in the prior period.

FDA 510(k) Review Time - EKX Product Code

FDA review times for EKX submissions have been consistent, averaging 176 days recently vs 184 days historically.

EKX devices are reviewed by the Dental panel. Browse all Dental devices →