EFAClass I

Handpiece, Belt And/Or Gear Driven, Dental

21 CFR 872.4200 / Dental

EFA is the FDA product code for Handpiece, Belt And/Or Gear Driven, Dental, a class I device type, regulated under 21 CFR 872.4200. As of 2026-09-10, FDA records hold 25 510(k) clearances under this code, the most recent dated 2020-08-25, and 3 recalls.

Classification record

Product code: EFA
Device name: Handpiece, Belt And/Or Gear Driven, Dental
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: 25
Ingested recalls: 3

Clearances, product code EFA

By decision year

25 clearances under product code EFA with a decision year between 1980 and 2020, 1996 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code EFA by decision year
Year	Clearances
1980	1
1987	1
1996	4
1997	4
2000	1
2001	1
2004	1
2006	2
2007	1
2009	4
2010	2
2015	1
2017	1
2020	1

Applicants with the most clearances

Product code EFA

Applicants holding the most 510(k) clearances under product code EFA
Applicant	Clearances
Anthogyr	3
Dentalez Group	3
Kaltenbach & Voigt GmbH	3
Dentsply Intl.	2
J. Morita USA, Inc.	2
Amc General, Inc.	1
Cranston Ind., Inc.	1
DPM USA Corp.	1
Est. Anthogyr	1
Medical Systems Group of Viskay, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order