DZJ — Driver, Wire, And Bone Drill, Manual Class II
FDA product code DZJ covers "Driver, Wire, And Bone Drill, Manual", a Class II medical device regulated under 21 CFR 872.4120. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261826 | 3d systems | VSP System (Titanium Palatal Splint) | June 3, 2026 |
| 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 |