Driver, Wire, And Bone Drill, Manual
Regulation 872.4120
2510(k)s in 12 months (33 all time)
0recalls in 12 months (11 all time)
9recalls that name a 510(k)
Top companies in DZJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Instruments Div. of Stryker Corporation | 0 | 8 |
| 3D Systems | 3 | 0 |
| Medical Modeling, Inc. | 2 | 1 |
| Artech Corp. | 2 | 0 |
| KLS-Martin L.P. | 2 | 0 |
| Materialise NV | 2 | 0 |
| Medcad | 2 | 0 |
| Propel Orthodontics, LLC | 2 | 0 |
| Straumann Manufacturing Inc. | 0 | 2 |
| Techfit Digital Surgery | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K260913 | CMF Titanium Splints Materialise NV, BE | DZJ |
| Jun 3, 2026 | K261826 | VSP System (Titanium Palatal Splint) 3D Systems, Inc. | DZJ |
| Feb 21, 2025 | K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery Materialise NV, BE | DZJ |
| Dec 11, 2024 | K242263 | TECHFIT DISRP® System Techfit Digital Surgery, Inc. | DZJ |
| Oct 2, 2023 | K231520 | tmCMF Solution Techmah Cmf | DZJ |
| Jun 23, 2023 | K230276 | TECHFIT DISRP® System Techfit Digital Surgery | DZJ |
| Mar 7, 2023 | K223024 | MedCAD AccuPlan System Medcad | DZJ |
| Sep 30, 2022 | K220366 | EmbedMed 3D Lifeprints UK , Ltd., GB | DZJ |
| Aug 11, 2022 | K220648 | OMF ASP System Vha Dean | DZJ |
| Feb 11, 2022 | K212570 | OsteoPlan System Osteomed, LLC | DZJ |
| Jun 28, 2021 | K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System Centermed, Inc. | DZJ |
| Jun 21, 2021 | K193301 | coDiagnostiX Dental Wings GmbH, DE | DZJ |
| Apr 26, 2021 | K210347 | VSP System 3D Systems | DZJ |
| Nov 4, 2020 | K193499 | DigiGuide System Protomed, Inc. | DZJ |
| Oct 29, 2020 | K192282 | MedCAD® AccuPlan® System Medcad | DZJ |
| Jun 9, 2020 | K181813 | ImmersiveView Surgical Plan (IVSP®) Immersivetouch | DZJ |
| Feb 26, 2020 | K192192 | VSP System 3D Systems | DZJ |
| Mar 11, 2019 | K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | DZJ |
| Sep 13, 2018 | K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System KLS-Martin L.P. | DZJ |
| Jan 17, 2018 | K172164 | PROPEL Device Propel Orthodontics, LLC | DZJ |
| Sep 18, 2015 | K150392 | PROPEL device Propel Orthodontics, LLC | DZJ |
| Jun 23, 2015 | K150796 | Dental Bone Cutting Instruments Synthes (USA) Products, LLC | DZJ |
| Jan 22, 2014 | K133907 | VSP SYSTEM Medical Modeling, Inc. | DZJ |
| Dec 12, 2012 | K120956 | VSP SYSTEM Medical Modeling, Inc. | DZJ |
| Apr 1, 2004 | K040369 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Instruments | DZJ |
| Nov 30, 1994 | K943540 | SURGICAL CUTTING BURS Stryker Corp. | DZJ |
| Oct 28, 1992 | K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. Sensor Medics Corp. | DZJ |
| Sep 27, 1989 | K894151 | IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT Artech Corp. | DZJ |
| Sep 27, 1989 | K894150 | COUNTERBORE FOR SS SUBMERGED SCREW PLANT Artech Corp. | DZJ |
| Dec 8, 1988 | K883922 | TECHMEDICA I.B.O. BLADE Techmedica, Inc. | DZJ |
| Jul 31, 1987 | K871834 | DRILL, HAND, BONE, SMEDBERG Military Engineering, Inc. | DZJ |
| Dec 28, 1978 | K781974 | IMPLANT DRIVERS AND TIPS Miter, Inc. | DZJ |
| Nov 19, 1976 | K760960 | SURGICAL WIRE DRIVER American Safety Equipment Corp. | DZJ |
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