Manufacturer registered with FDA
Fussen Imaging Co.,Ltd.
Shenzhen, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 45 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Fussen Imaging Co.,Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Fussen Imaging Co.,Ltd. | 1 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Fussen Imaging Co.,Ltd. | 3 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Fussen Imaging Co.,Ltd. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Fussen Imaging Co.,Ltd. | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Fussen Imaging Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Digital Intraoral Scanner System(Model:S10, S10P Wireless, S10L Wireless, S10E Wireless, S10D Wireless) | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FUSSEN IMAGING CO.,LTD.FDA reg. 3044905014 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095395). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.