Data / Medical devices / China / Shenzhen Upcera Dental Technology Co., Ltd
Shenzhen Upcera Dental Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 9 510(k) clearances
Shenzhen Upcera Dental Technology Co., Ltd is registered with the FDA (registration 3012441963) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012441963
- Address
- 2nd Floor, Tsinghua IT Port B High-tech Park, Nanshan District, Shenzhen Guangdong, China, 518057
- Owner or operator
- Shenzhen Upcera Dental Technology Co., Ltd (10052091)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- June 12, 2016
- Registered through
- 2026
- Brand names listed
- Adhesive Tip Applicator, DUO, Aevra, Dental Zirconia Blank for Aesthetic Restoration, EnduraCem; EsCem, Glaze Paste, Glaze Powder, and Glaze Liquid, Gradual Dental Zirconia Blank, Hyramic CAD/CAM Restorative, Optrastick and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Foreign private label distributor | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Exporter to the US | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Exporter to the US | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Exporter to the US | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Exporter to the US | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| March 2, 2026 | K253380 | FLNT Base and FLNT Temp | EBG | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| January 9, 2026 | K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| September 7, 2023 | K231687 | Gradual Dental Zirconia Blank | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| September 2, 2018 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| January 12, 2017 | K162323 | Tooth Shade Resin Material | EBF | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| December 4, 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| December 18, 2014 | K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| October 22, 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
| October 22, 2014 | K141723 | UPCERA COLORING LIQUID (I AND II ) | EIH | Substantially Equivalent | Liaoning Upcera Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Powder, Porcelain
- All makers of Material, Tooth Shade, Resin
- All makers of Instruments, Dental Hand
- All makers of Cement, Dental
Updated March 2, 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.