DZI
- Product code
- DZI
- Device name
- Drill, Bone, Powered
- 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)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 50 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253655 | 2026-07-31 | W&H Dentalwerk Bürmoos GmbH | Angled Screwdriver MED (M-SD090) | |
| K253776 | 2026-06-18 | W&H Dentalwerk Buermoos GmbH | Implantmed Plus II & Piezomed Plus II Module | |
| K254163 | 2025-12-23 | Nakanishi, Inc. | VarioSurg 4 | |
| K242432 | 2024-08-19 | Mectron S.P.A. | MT-Bone | |
| K240340 | 2024-07-18 | Guangdong Jinme Medical Technology Co.… | Surgical Drive System (Model: ES70, ES90, E8) |
Official FDA classification page: DZI
Classification and pathway per current FDA publications. Data from openFDA (CC0).