DZJ · Class II · 21 CFR 872.4120

FDA Product Code DZJ: Driver, Wire, And Bone Drill, Manual

Leading manufacturers include Propel Orthodontics, LLC, KLS-Martin L.P. and 3D Systems.

33
Total
33
Cleared
185d
Avg days
1976
Since
Growing category - 4 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 107d recently vs 196d historically

FDA 510(k) Cleared Driver, Wire, And Bone Drill, Manual Devices (Product Code DZJ)

33 devices
1–24 of 33
Cleared Oct 09, 2026
CMF Titanium Splints
K260913
Materialise NV
Dental · 204d
Cleared Jun 03, 2026
VSP System (Titanium Palatal Splint)
K261826
3D Systems, Inc.
Dental · 2d
Cleared Feb 21, 2025
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
K243637
Materialise NV
Dental · 88d
Cleared Dec 11, 2024
TECHFIT DISRP® System
K242263
Techfit Digital Surgery, Inc.
Dental · 132d
Cleared Oct 02, 2023
tmCMF Solution
K231520
Techmah Cmf
Dental · 130d
Cleared Jun 23, 2023
TECHFIT DISRP® System
K230276
Techfit Digital Surgery
Dental · 142d
Cleared Mar 07, 2023
MedCAD AccuPlan System
K223024
Medcad
Dental · 159d
Cleared Sep 30, 2022
EmbedMed
K220366
3D Lifeprints UK , Ltd.
Dental · 234d
Cleared Aug 11, 2022
OMF ASP System
K220648
Vha Dean
Dental · 157d
Cleared Feb 11, 2022
OsteoPlan System
K212570
Osteomed, LLC
Dental · 179d
Cleared Jun 28, 2021
CenterMed Patient Matched Assisted Surgical Planning (ASP) System
K201353
Centermed, Inc.
Dental · 403d
Cleared Jun 21, 2021
coDiagnostiX
K193301
Dental Wings GmbH
Dental · 570d
Cleared Apr 26, 2021
VSP System
K210347
3D Systems
Dental · 77d
Cleared Nov 04, 2020
DigiGuide System
K193499
Protomed, Inc.
Dental · 323d
Cleared Oct 29, 2020
MedCAD® AccuPlan® System
K192282
Medcad
Dental · 434d
Cleared Jun 09, 2020
ImmersiveView Surgical Plan (IVSP®)
K181813
Immersivetouch
Dental · 704d
Cleared Feb 26, 2020
VSP System
K192192
3D Systems
Dental · 197d
Cleared Mar 11, 2019
KLS Martin Individual Patient Solutions (IPS) Planning System
K182789
KLS-Martin L.P.
Dental · 161d
Cleared Sep 13, 2018
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241
KLS-Martin L.P.
Dental · 126d
Cleared Jan 17, 2018
PROPEL Device
K172164
Propel Orthodontics, LLC
Dental · 183d
Cleared Sep 18, 2015
PROPEL device
K150392
Propel Orthodontics, LLC
Dental · 212d
Cleared Jun 23, 2015
Dental Bone Cutting Instruments
K150796
Synthes USA Products, LLC
Dental · 89d
Cleared Jan 22, 2014
VSP SYSTEM
K133907
Medical Modeling, Inc.
Dental · 30d
Cleared Dec 12, 2012
VSP SYSTEM
K120956
Medical Modeling, Inc.
Dental · 257d

About Product Code DZJ - Regulatory Context

510(k) Submission Activity

33 total 510(k) submissions under product code DZJ since 1976, with 33 receiving FDA clearance (average review time: 185 days).

Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DZJ Product Code

Recent submissions under DZJ have taken an average of 107 days to reach a decision - down from 196 days historically, suggesting improved FDA processing for this classification.

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