FDA device listing
3D Scanner D1000,3D Scanner D2000,3D scanner D500,3D Scanner D700,3D scanner D710,3D Scanner D750,3D Scanner D800,3D…
FDA device listing 1035002055 · 3Shape A/S
Key facts
| Proprietary names | 3D Scanner D1000,3D Scanner D2000,3D scanner D500,3D Scanner D700,3D scanner D710,3D Scanner D750,3D Scanner D800,3D Scanner D810,3D Scanner D850,3D scanner D900,3D scanner D900L,3D Scanner R1000,3D Scanner R2000,3D scanner R500,3D Scanner R700,3D scanner R710,3D Scanner R750,3D Scanner R850,3D scanner R900,3Shape Anatomy Design,3Shape Dental System,3Shape F8,Automate,E1 scanner,E2 Scanner,E3… |
|---|---|
| Owner/operator | 3Shape A/S |
| Owner/operator number | 10023901 |
| Product codes | NOF |
| Device names | NOF - System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3661 |
| Review panels | Dental |
| Registered establishments | 3Shape A/S, 3shape inc, 3Shape Inc., 3Shape Poland Sp. zo.o |
| Establishment registrations | 3005940400, 3010728558, 3015172511, 3015193486 |
| FEI numbers | 3005940400, 3010728558, 3015172511, 3015193486 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, 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