Data / Medical devices / China / Fussen Technology Co., Ltd
Fussen Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 3 510(k) clearances
Fussen Technology Co., Ltd is registered with the FDA (registration 3018999255) in Shenzhen Guangdong, China. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 30, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3018999255
- Address
- 901,1001, Building #D1, Nanshan Zhiyuan, 1001 Xueyuan Avenue Changyuan Community, Taoyuan Street, Nanshan District, Shenzhen Guangdong, China, 518055
- Owner or operator
- Fussen Technology Co., Ltd (10081508)
- Roles
- Manufacturer
- First device listed
- April 21, 2021
- Registered through
- 2027
- Brand names listed
- Dental Computed Tomography X-ray System, Digital Intraoral Imaging Plate System, Fussen, Digital Intraoral Scanner System S6000, Fussen, Digital Intraoral Scanner System S6500, Fussen, Digital Intraoral Scanner System S7000 S7000 Premium, Fussen,Digital Intraoral Scanner System S10, Rubik XSmart
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Extraoral Source, Digital | MUH | 2 | Manufacturer | accessdata.fda.gov |
| X-Ray, Tomography, Computed, Dental | OAS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 30, 2026 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | OAS | Substantially Equivalent | Fussen Technology Co., Ltd. | accessdata.fda.gov |
| November 13, 2025 | K251842 | Dental Computed Tomography X-ray System | OAS | Substantially Equivalent | Fussen Technology Co., Ltd. | accessdata.fda.gov |
| December 5, 2019 | K192766 | Digital Intraoral Imaging Plate System | MUH | Substantially Equivalent | Fsusen Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of X-Ray, Tomography, Computed, Dental
- All makers of System, X-Ray, Extraoral Source, Digital
Updated September 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.