DZJClass II

Driver, Wire, And Bone Drill, Manual

21 CFR 872.4120 / Dental

DZJ is the FDA product code for Driver, Wire, And Bone Drill, Manual, a class II device type, regulated under 21 CFR 872.4120. As of 2026-09-10, FDA records hold 32 510(k) clearances under this code, the most recent dated 2026-06-03, and 11 recalls.

Classification record

Product code: DZJ
Device name: Driver, Wire, And Bone Drill, Manual
Regulation: 21 CFR 872.4120
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 32
Ingested recalls: 11

Clearances, product code DZJ

By decision year

32 clearances under product code DZJ with a decision year between 1976 and 2026, 2020 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code DZJ by decision year
Year	Clearances
1976	1
1978	1
1987	1
1988	1
1989	2
1992	1
1994	1
2004	1
2012	1
2014	1
2015	2
2018	2
2019	1
2020	4
2021	3
2022	3
2023	3
2024	1
2025	1
2026	1

Applicants with the most clearances

Product code DZJ

Applicants holding the most 510(k) clearances under product code DZJ
Applicant	Clearances
3D Systems, Inc.	3
Artech Corp.	2
KLS-Martin L.P.	2
MedCAD	2
Medical Modeling - a 3D Systems Company	2
Propel Orthodontics, LLC	2
Stryker Corp.	2
Techfit Digital Surgery, Inc.	2
3D Lifeprints UK, Ltd.	1
American Safety Equipment Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order