FDA device listing
AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro;,Owandy…
FDA device listing 1226294193 · Shanghai Smartee Denti-Technology Co., Ltd.
Key facts
| Proprietary names | AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro;,Owandy ios; Owandy ios Wireless; ST 200E |
|---|---|
| Owner/operator | Shanghai Smartee Denti-Technology Co., Ltd. |
| Owner/operator number | 10060314 |
| 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 | SHANGHAI SMARTEE DENTI-TECHNOLOGY CO., LTD. |
| Establishment registrations | 3015342395 |
| FEI numbers | 3015342395 |
| Establishment operations | Foreign Exporter |
| 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