DZJ
- Product code
- DZJ
- Device name
- Driver, Wire, And Bone Drill, Manual
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.4120
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 32 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261826 | 2026-06-03 | 3D Systems, Inc. | VSP System (Titanium Palatal Splint) | |
| K243637 | 2025-02-21 | Materialise NV | Materialise Personalized Guides and Models for Crani… | |
| K242263 | 2024-12-11 | Techfit Digital Surgery, Inc. | TECHFIT DISRP® System | |
| K231520 | 2023-10-02 | Techmah Cmf | tmCMF Solution |
Official FDA classification page: DZJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).