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 Cefla S.C., Nakanishi, Inc. and Dentsply Sirona, Inc..

5
Total
5
Cleared
242d
Avg days
2022
Since

List of Controller, Foot, Handpiece And Cord devices cleared through 510(k)

5 devices
1–5 of 5
Cleared Aug 25, 2025
Motor and Apex Module (MaAM)
K251811
Dentsply Sirona, Inc.
Dental · 74d
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 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

How to use this database

This page lists all FDA 510(k) submissions for Controller, Foot, Handpiece And Cord devices (product code EBW). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Dental FDA review panel. Browse all Dental devices →