Shenzhen UP3D Tech Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 2 device types, 2 products catalogued, 1 clearance.
Shenzhen UP3D Tech Co., Ltd. is a repacker / relabeller holding a current FDA establishment registration. The registration covers Powder, Porcelain, System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | SHENZHEN UP3D TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017619362 |
| FEI number | 3017619362 |
| DUNS | 403391939 |
| Establishment type | Repacker / relabeller, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳云甲科技有限公司 |
|---|---|
| Unified social credit code | 91440300342624788R |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 401, Block B, Nanshan Yungu Nanfeng Tower, 4093 Liuxian Avenue, Nanshan District |
| Postal code | 518055 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powder, Porcelain | Class 2 | POWDER, PORCELAIN-Dental Glass Ceramic, POWDER, PORCELAIN-Dental Zirconia Blocks | 2023 | 33 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | 3D Scanner,UP300E, 3D Scanner,UP500, Intraoral ScannerUP600,UP610, 3D Scanner,UP200, 3D Scanner, UP1000, 3D Scanner,UP300S and 8 more | 2020 | 36 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Soreal CAD | EIH | 1 |
| UP3D Intraoral Scanner | NOF | 1 |
Clearances
1 clearance names Shenzhen UP3D Tech 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 |
|---|---|---|---|---|
| K230259 | 2023-05-25 | EIH | Traditional | This company |
| K192262 | 2020-05-29 | EIH | Traditional | DE Corematrix Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Employees | 200+ |
|---|---|
| Main products | digital dental scanners, CAD/CAM milling machines, dental design software |
| Export markets | China and international markets |
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.