Manufacturer registered with FDA
Shenzhen UP3D Tech Co., Ltd.
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 610 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Shenzhen UP3D Tech 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 | Shenzhen UP3D Tech Co., Ltd. | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Shenzhen UP3D Tech Co., LtdShenzhen UP3D Tech Co., Ltd. | 4 | 2024–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHENZHEN UP3D TECH CO., LTD | 3 | 2024–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shenzhen UP3D Tech Co., Ltd. | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHENZHEN UP3D TECH CO., LTD. | 1 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shenzhen Up3D Tech Co.,Ltd | 1 | 2015–2015 | 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 Shenzhen UP3D Tech 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | POWDER, PORCELAIN-Dental Glass CeramicPOWDER, PORCELAIN-Dental Zirconia Blocks | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral ScannerUP600,UP6103D Scanner, UP10003D Scanner, UP4003D Scanner,UP2003D Scanner,UP3003D Scanner,UP300E3D Scanner,UP300PH3D Scanner,UP300PM3D Scanner,UP300S3D Scanner,UP360 4 more3D Scanner,UP5003D Scanner,UP560 (H. M)3D Scanner,UP560HD3D Scanner,UP560ProH | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Shenzhen UP3D Tech 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: Shenzhen Up3D Technology Co., Ltd. (1), De Corematrix Co.Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 25 May 2023 | K230259 | Soreal Press, Soreal CAD | Shenzhen Up3D Technology Co., Ltd. | EIH Porcelain Powder |
| 29 May 2020 | K192262 | Dental Zirconia Blocks | De Corematrix Co.Ltd. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN UP3D TECH CO., LTD.FDA reg. 3017619362 | Shenzhen Guangdong, China | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078226). 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.