EBWClass I

Controller, Foot, Handpiece And Cord

21 CFR 872.4200 / Dental

EBW is the FDA product code for Controller, Foot, Handpiece And Cord, a class I device type, regulated under 21 CFR 872.4200. As of 2026-09-10, FDA records hold 61 510(k) clearances under this code, the most recent dated 2026-01-30, and 2 recalls.

Classification record

Product code: EBW
Device name: Controller, Foot, Handpiece And Cord
Regulation: 21 CFR 872.4200
Device class: Class I
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 61
Ingested recalls: 2

Clearances, product code EBW

By decision year

61 clearances under product code EBW with a decision year between 1977 and 2026, 2022 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code EBW by decision year
Year	Clearances
1977	1
1979	1
1991	1
1997	3
1998	1
1999	1
2000	2
2001	2
2002	2
2003	2
2004	2
2006	2
2009	5
2010	1
2011	3
2012	1
2013	1
2014	3
2015	1
2016	1
2017	4
2018	1
2019	2
2020	1
2021	2
2022	6
2024	4
2025	3
2026	2

Applicants with the most clearances

Product code EBW

Applicants holding the most 510(k) clearances under product code EBW
Applicant	Clearances
Nakanishi Inc.	7
W & H DentalWerk Buermoos GmbH	5
Micro-NX Co., Ltd.	3
Saeshin Precision Co., Ltd.	3
A-dec, Inc.	2
Bell Intl., Inc.	2
Cefla S.C.	2
Dentsply Sirona Inc	2
Guilin Woodpecker Medical Instrument Co., Ltd	2
Kaltenbach & Voigt GmbH	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 66 companies shown, in name order