DZJ — Driver, Wire, And Bone Drill, Manual Class II
FDA Device Classification
Classification Details
- Product Code
- DZJ
- Device Class
- Class II
- Regulation Number
- 872.4120
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243637 | materialise | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | February 21, 2025 |
| K242263 | techfit digital surgery | TECHFIT DISRP® System | December 11, 2024 |
| K231520 | techmah cmf | tmCMF Solution | October 2, 2023 |
| K230276 | techfit digital surgery | TECHFIT DISRP® System | June 23, 2023 |
| K223024 | medcad | MedCAD AccuPlan System | March 7, 2023 |
| K220366 | 3d lifeprints uk | EmbedMed | September 30, 2022 |
| K220648 | vha dean | OMF ASP System | August 11, 2022 |
| K212570 | osteomed | OsteoPlan System | February 11, 2022 |
| K201353 | centermed | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | June 28, 2021 |
| K193301 | dental wings | coDiagnostiX | June 21, 2021 |
| K210347 | 3d systems | VSP System | April 26, 2021 |
| K193499 | protomed | DigiGuide System | November 4, 2020 |
| K192282 | medcad | MedCAD® AccuPlan® System | October 29, 2020 |
| K181813 | immersivetouch | ImmersiveView Surgical Plan (IVSP®) | June 9, 2020 |
| K192192 | 3d systems | VSP System | February 26, 2020 |
| K182789 | kls-martin l.p | KLS Martin Individual Patient Solutions (IPS) Planning System | March 11, 2019 |
| K181241 | kls-martin l.p | KLS Martin Individual Patient Solutions (IPS) Planning System | September 13, 2018 |
| K172164 | propel orthodontics | PROPEL Device | January 17, 2018 |
| K150392 | propel orthodontics | PROPEL device | September 18, 2015 |
| K150796 | synthes (usa) products | Dental Bone Cutting Instruments | June 23, 2015 |