EKX · Class I · 21 CFR 872.4200

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

Leading manufacturers include Perimetrics, Inc., Guilin Woodpecker Medical Instrument Co., Ltd. and Meta Systems Co., Ltd..

89
Total
89
Cleared
183d
Avg days
1976
Since
Growing category - 9 submissions in the last 2 years vs 6 in the prior period
Review times increasing: avg 257d recently vs 175d historically

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 increased in recent years - 9 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EKX Product Code

Recent submissions under EKX have taken an average of 257 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.

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