Data / Medical devices / China / Shenzhen Up3d Tech Co., Ltd.
Shenzhen Up3d Tech Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 2 510(k) clearances
Shenzhen Up3d Tech Co., Ltd. is registered with the FDA (registration 3017619362) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 25, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017619362
- Address
- 401, Block B, Nanshan Yungu Nanfeng Tower, 4093 Liuxian Avenue, Nanshan District, Shenzhen Guangdong, China, 518055
- Owner or operator
- Shenzhen UP3D Tech Co., Ltd. (10078226)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 15, 2020
- Registered through
- 2026
- Brand names listed
- 3D Scanner, UP1000, 3D Scanner, UP400, 3D Scanner,UP200, 3D Scanner,UP300, 3D Scanner,UP300E, 3D Scanner,UP300PH, 3D Scanner,UP300PM, 3D Scanner,UP300S and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 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 |
|---|---|---|---|---|---|---|
| May 25, 2023 | K230259 | Soreal Press, Soreal CAD | EIH | Substantially Equivalent | Shenzhen Up3D Technology Co., Ltd. | accessdata.fda.gov |
| May 29, 2020 | K192262 | Dental Zirconia Blocks | EIH | Substantially Equivalent | De Corematrix Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Updated May 25, 2023. 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.