FDA device listing
Digital Intraoral Scanner System(Model:S10, S10P Wireless, S10L Wireless, S10E Wireless, S10D Wireless)
FDA device listing 1415187860 · Fussen Imaging Co.,Ltd.
Key facts
| Proprietary names | Digital Intraoral Scanner System(Model:S10, S10P Wireless, S10L Wireless, S10E Wireless, S10D Wireless) |
|---|---|
| Owner/operator | Fussen Imaging Co.,Ltd. |
| Owner/operator number | 10095395 |
| 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 | FUSSEN IMAGING CO.,LTD. |
| Establishment registrations | 3044905014 |
| FEI numbers | 3044905014 |
| Establishment operations | Manufacturer |
| 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