FDA device listing
3DDX AOX Kit,3DDX Drills,3DDX Fixation Pins,3DDX Keys,3DDX Surgical Guide,3DDX Tissue Punch
FDA device listing 1871392427 · 3D Diagnostix inc
Key facts
| Proprietary names | 3DDX AOX Kit,3DDX Drills,3DDX Fixation Pins,3DDX Keys,3DDX Surgical Guide,3DDX Tissue Punch |
|---|---|
| Owner/operator | 3D Diagnostix inc |
| Owner/operator number | 10049937 |
| Product codes | NDP |
| Device names | NDP - Accessories, Implant, Dental, Endosseous |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.3980 |
| Review panels | Dental |
| Registered establishments | 3D DIAGNOSTIX INC |
| Establishment registrations | 3011429437 |
| FEI numbers | 3011429437 |
| Establishment operations | Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database