Atlas FDA

DZJ

32 FDA 510(k) clearances · Product code

142 daysmedian time to decision
403 days90th percentile
32clearances measured

FDA profile

Official device name
Driver, Wire, And Bone Drill, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2016: 16 · 2020: 17 · 2021: 22 · 2022: 23 · 2023: 22 · 2026: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VSP System (Titanium Palatal Splint) (K261826)3D Systems, Inc.2026-06-03
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (K243637)Materialise NV2025-02-21
TECHFIT DISRP® System (K242263)Techfit Digital Surgery, Inc.2024-12-11
tmCMF Solution (K231520)Techmah Cmf2023-10-02
TECHFIT DISRP® System (K230276)Techfit Digital Surgery2023-06-23
MedCAD AccuPlan System (K223024)Medcad2023-03-07
EmbedMed (K220366)3D Lifeprints UK , Ltd.2022-09-30
OMF ASP System (K220648)Vha Dean2022-08-11
OsteoPlan System (K212570)Osteomed, LLC2022-02-11
CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353)Centermed, Inc.2021-06-28
coDiagnostiX (K193301)Dental Wings GmbH2021-06-21
VSP System (K210347)3D Systems2021-04-26
DigiGuide System (K193499)Protomed, Inc.2020-11-04
MedCAD® AccuPlan® System (K192282)Medcad2020-10-29
ImmersiveView Surgical Plan (IVSP®) (K181813)Immersivetouch2020-06-09
VSP System (K192192)3D Systems2020-02-26
KLS Martin Individual Patient Solutions (IPS) Planning System (K182789)KLS-Martin L.P.2019-03-11
KLS Martin Individual Patient Solutions (IPS) Planning System (K181241)KLS-Martin L.P.2018-09-13
PROPEL Device (K172164)Propel Orthodontics, LLC2018-01-17
PROPEL device (K150392)Propel Orthodontics, LLC2015-09-18
Dental Bone Cutting Instruments (K150796)Synthes (USA) Products, LLC2015-06-23
VSP SYSTEM (K133907)Medical Modeling, Inc.2014-01-22
VSP SYSTEM (K120956)Medical Modeling, Inc.2012-12-12
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K040369)Stryker Instruments2004-04-01
SURGICAL CUTTING BURS (K943540)Stryker Corp.1994-11-30
SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. (K915848)Sensor Medics Corp.1992-10-28
COUNTERBORE FOR SS SUBMERGED SCREW PLANT (K894150)Artech Corp.1989-09-27
IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT (K894151)Artech Corp.1989-09-27
TECHMEDICA I.B.O. BLADE (K883922)Techmedica, Inc.1988-12-08
DRILL, HAND, BONE, SMEDBERG (K871834)Military Engineering, Inc.1987-07-31
IMPLANT DRIVERS AND TIPS (K781974)Miter, Inc.1978-12-28
SURGICAL WIRE DRIVER (K760960)American Safety Equipment Corp.1976-11-19

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Every clearance here is in the API, with alerts when new ones post.