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 |
|---|---|---|---|
| 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 |
| K781974 | IMPLANT DRIVERS AND TIPS | Miter, Inc. | 1978-12-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327652772 | TPX | STRYKER CORPORATION | 2026-04-13 |
| 07613327504057 | NA | STRYKER CORPORATION | 2021-07-08 |
| 10887587013510 | NA | Synthes GmbH | 2018-09-21 |
| 10887587013503 | NA | Synthes GmbH | 2018-09-21 |
| 10887587013497 | NA | Synthes GmbH | 2018-09-21 |
| 10887587013480 | MatrixMIDFACE | Synthes GmbH | 2018-09-21 |
| 10887587013473 | MatrixMIDFACE | Synthes GmbH | 2018-09-21 |
| 10887587013466 | MatrixMIDFACE | Synthes GmbH | 2018-09-21 |
| 10887587013442 | NA | Synthes GmbH | 2018-09-21 |
| 10887587013435 | NA | Synthes GmbH | 2018-09-21 |
| 10887587013428 | MatrixMIDFACE | Synthes GmbH | 2018-09-21 |
| 10887587013411 | MatrixMIDFACE | Synthes GmbH | 2018-09-21 |
| 10886982187284 | NA | Synthes GmbH | 2018-07-18 |
| 10886982187291 | NA | Synthes GmbH | 2018-07-18 |
| 10887587002002 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10886982129208 | NA | Synthes GmbH | 2016-06-30 |
| 10887587001951 | MatrixMANDIBLE | Synthes GmbH | 2016-06-30 |
| 10887587001968 | MatrixMANDIBLE | Synthes GmbH | 2016-06-30 |
| 10887587001975 | MatrixMANDIBLE | Synthes GmbH | 2016-06-30 |
| 10887587001982 | NA | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10887587001999 | Matrix | SYNTHES (U.S.A.) LP | 2016-06-30 |
| 10887587013305 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013299 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013374 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013367 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013350 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013343 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013336 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013329 | NA | Synthes GmbH | 2016-06-30 |
| 10887587013312 | NA | Synthes GmbH | 2016-06-30 |