Product code DZJ
- Device name
- Driver, Wire, And Bone Drill, Manual
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.4120
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | 2026-06-03 |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | 2025-02-21 |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | 2024-12-11 |
| K231520 | tmCMF Solution | Techmah Cmf | 2023-10-02 |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | 2023-06-23 |
| K223024 | MedCAD AccuPlan System | Medcad | 2023-03-07 |
| K220366 | EmbedMed | 3D Lifeprints UK , Ltd. | 2022-09-30 |
| K220648 | OMF ASP System | Vha Dean | 2022-08-11 |
| K212570 | OsteoPlan System | Osteomed, LLC | 2022-02-11 |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | 2021-06-28 |
| K193301 | coDiagnostiX | Dental Wings GmbH | 2021-06-21 |
| K210347 | VSP System | 3D Systems | 2021-04-26 |
| K193499 | DigiGuide System | Protomed, Inc. | 2020-11-04 |
| K192282 | MedCAD® AccuPlan® System | Medcad | 2020-10-29 |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | 2020-06-09 |
| K192192 | VSP System | 3D Systems | 2020-02-26 |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2019-03-11 |
| K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | 2018-09-13 |
| K172164 | PROPEL Device | Propel Orthodontics, LLC | 2018-01-17 |
| K150392 | PROPEL device | Propel Orthodontics, LLC | 2015-09-18 |
| K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | 2015-06-23 |
| K133907 | VSP SYSTEM | Medical Modeling, Inc. | 2014-01-22 |
| K120956 | VSP SYSTEM | Medical Modeling, Inc. | 2012-12-12 |
| K040369 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM | Stryker Instruments | 2004-04-01 |
| K943540 | SURGICAL CUTTING BURS | Stryker Corp. | 1994-11-30 |
| K915848 | SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB. | Sensor Medics Corp. | 1992-10-28 |
| K894150 | COUNTERBORE FOR SS SUBMERGED SCREW PLANT | Artech Corp. | 1989-09-27 |
| K894151 | IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT | Artech Corp. | 1989-09-27 |
| K883922 | TECHMEDICA I.B.O. BLADE | Techmedica, Inc. | 1988-12-08 |
| K871834 | DRILL, HAND, BONE, SMEDBERG | Military Engineering, Inc. | 1987-07-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816847020664 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020800 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020794 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020787 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020770 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020763 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020756 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020749 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020732 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020725 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020718 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020701 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020695 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020688 | VSP System, VSP Cranial | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020671 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020510 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020657 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020640 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020633 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020626 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020619 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020602 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020596 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020589 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020572 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020565 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020558 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020541 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020534 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |
| 00816847020527 | VSP System | 3D SYSTEMS, INC. | 2016-09-12 |