Fussen Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 3 device types, 3 products catalogued, 1 clearance.
Fussen Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers X-Ray, Tomography, Computed, Dental, System, X-Ray, Extraoral Source, Digital and 1 other device type. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | FUSSEN TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3018999255 |
| FEI number | 3018999255 |
| DUNS | 543062347 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市菲森科技有限公司 |
|---|---|
| Unified social credit code | 91440300761976585D |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 901,1001, Building #D1, Nanshan Zhiyuan, 1001 Xueyuan Avenue |
| Postal code | 518055 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | Fussen, Digital Intraoral Scanner System S6000, Fussen, Digital Intraoral Scanner System S6500, Fussen,Digital Intraoral Scanner System S10, Fussen, Digital Intraoral Scanner System S7000 S7000 Premium | 2021 | 36 |
| System, X-Ray, Extraoral Source, Digital | Class 2 | Digital Intraoral Imaging Plate System | 2024 | 10 |
| X-Ray, Tomography, Computed, Dental | Class 2 | Dental Computed Tomography X-ray System | 2025 | 4 |
Own-Brand Listings
Clearances
1 clearance names Fussen Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251842 | 2025-11-13 | OAS | Traditional | This company |
| K192766 | 2019-12-05 | MUH | Traditional | Fsusen Technology Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Factory area | 7200 m² (China), 1000 m² (Germany) |
| Main products | CBCT systems, intraoral scanners, dental imaging systems, DentalX software, DentalFlex software |
| Certifications | ISO 13485, CE, FDA, NMPA |
| Export markets | Over 80 countries worldwide |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.