Manufacturer registered with FDA
Fussen Technology Co., Ltd
Shenzhen, China. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 7
- 510(k) clearances
- 22025–2026
- Markets registered in
- 1145 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Fussen Technology 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 Technology Co., Ltd | 2 clearances | 2025–2026 | Below |
| European Union | EUDAMED | Manufacturer | Fussen Technology Co., Ltd. | 10 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Fussen Technology Co.,Ltd. | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Fussen Technology Co.,LtdFUSSEN TECHNOLOGY Co.,Ltd · Fussen Technology Co LTD · +1 | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Fussen Technology Co., Ltd.FUSSEN TECHNOLOGY CO., LTD. | 5 | 2019–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Fussen Technology Co Ltd | 4 | 2018–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | FUSSEN TECHNOLOGY CO.,LTD.FUSSEN TECHNOLOGY CO. LTD | 4 | 2021–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Fussen Technology Co., LtdFussen Technology Co,. Ltd | 3 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Fussen Technology Co., Ltd. | 3 | 2025–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | FUSSEN TECHNOLOGY CO., LTD | 2 | 2023–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Fussen Technology Co.,Ltd. | 1 | 2025–2025 | 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 Technology 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 |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Dental Computed Tomography X-ray SystemRubik XSmart | 2025 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | Digital Intraoral Imaging Plate System | 2024 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Fussen, Digital Intraoral Scanner System S6000Fussen, Digital Intraoral Scanner System S6500Fussen, Digital Intraoral Scanner System S7000 S7000 PremiumFussen,Digital Intraoral Scanner System S10 | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Fussen Technology Co., Ltd as the applicant.
Also lists devices cleared under other names
Fussen Technology Co., Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Fsusen Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Dec 2019 | K192766 | Digital Intraoral Imaging Plate System | Fsusen Technology Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| FUSSEN TECHNOLOGY CO., LTDFDA reg. 3018999255 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10081508). 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.