EBW · Class I · 21 CFR 872.4200

FDA Product Code EBW: Controller, Foot, Handpiece And Cord

FDA product code EBW covers foot controllers, dental handpiece bodies, and cords used as accessories in dental procedures.

These components enable hands-free speed control of dental handpieces through foot pedal activation, allowing the clinician to adjust rotational speed without removing hands from the operative field. They are used with air-driven and electric dental handpiece systems.

EBW devices are Class I medical devices, regulated under 21 CFR 872.4200 and reviewed by the FDA Dental panel.

Leading manufacturers include Micro-Nx Co., Ltd., Nakanishi, Inc. and Saeshin Precision Co., Ltd..

61
Total
61
Cleared
212d
Avg days
1977
Since
Stable submission activity - 5 submissions in the last 2 years
Review times increasing: avg 313d recently vs 203d historically

FDA 510(k) Cleared Controller, Foot, Handpiece And Cord Devices (Product Code EBW)

61 devices
1–24 of 61
Cleared Jan 30, 2026
Motor Handpiece and Control Unit (SDI10)
K251407
Saeshin Precision Co., Ltd.
Dental · 269d
Cleared Jan 12, 2026
Star E900 Electric System
K251701
Dentalez, Inc., Stardental Division
Dental · 224d
Cleared Aug 25, 2025
Motor and Apex Module (MaAM)
K251811
Dentsply Sirona, Inc.
Dental · 74d
Cleared Jul 18, 2025
ELEC ENGINE (Model: ISE-170L)
K231562
Micro-Nx Co., Ltd.
Dental · 779d
Cleared Apr 11, 2025
Dental Implant Unit
K242646
Guilin Aesthedent Medical Instruments Co., Ltd.
Dental · 220d
Cleared Jun 24, 2024
NLZ Built-In Motor System
K233288
Nakanishi, Inc.
Dental · 269d
Cleared Jun 20, 2024
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
K233117
Nakanishi, Inc.
Dental · 267d
Cleared Apr 01, 2024
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO
K230895
Cefla S.C.
Dental · 367d
Cleared Mar 11, 2024
Fiber Optic Brushless Electronic Micromotor, model: iM100
K231864
Codent Technical Industry Co., Ltd.
Dental · 259d
Cleared Nov 21, 2022
Implanter incl. Accessories
K211358
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 567d
Cleared Sep 27, 2022
Dental Implantation Systems, Dental Electrical Motors
K220831
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 189d
Cleared May 09, 2022
CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED
K213022
Cefla S.C.
Dental · 231d
Cleared Mar 11, 2022
Dental Electric Motor
K202075
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 592d
Cleared Feb 07, 2022
ELEC-LED
K201191
Micro-Nx Co., Ltd.
Dental · 644d
Cleared Jan 13, 2022
Dental Electric Motor
K203706
Guilin Woodpecker Medical Instrument Co., Ltd.
Dental · 391d
Cleared May 21, 2021
Impla-NX (Model: ISE-270M)
K201192
Micro-Nx Co., Ltd.
Dental · 382d
Cleared Feb 11, 2021
TRAUS SIP20
K201292
Saeshin Precision Co., Ltd.
Dental · 273d
Cleared Sep 04, 2020
iCTmotor (WL-1)
K193341
Dentium Co., Ltd.
Dental · 276d
Cleared Jul 25, 2019
Maxima Electric System
K180845
Handpiece Headquarters - Hpr, Inc.
Dental · 479d
Cleared Mar 26, 2019
Electric Handpiece Motor
K181858
W&H Dentalwerk Buermoos GmbH
Dental · 257d
Cleared Jun 19, 2018
Surgic Pro, Surgic Pro+
K173905
Nakanishi, Inc.
Dental · 179d

About Product Code EBW - Regulatory Context

510(k) Submission Activity

61 total 510(k) submissions under product code EBW since 1977, with 61 receiving FDA clearance (average review time: 212 days).

Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.

FDA 510(k) Review Time - EBW Product Code

Recent submissions under EBW have taken an average of 313 days to reach a decision - up from 203 days historically. Manufacturers should account for longer review timelines in current project planning.

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