Data / Medical devices / China / Shenzhen Upcera Digital Dental Technology Co., Ltd
Shenzhen Upcera Digital Dental Technology Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 10 510(k) clearances
Shenzhen Upcera Digital Dental Technology Co., Ltd is registered with the FDA (registration 3039433962) in Shenzhen Guangdong, China. It lists 10 device types. The FDA files 10 510(k) clearances under its listings, the newest dated March 2, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3039433962
- Address
- Floor 5, R&D Building B, Tsinghua IT Port, No. 1 Xindong Road, Songping Shan Community, Xili Sub-District, Nan, Shenzhen Guangdong, China, 117004
- Owner or operator
- Shenzhen Upcera Digital Dental Technology Co., Ltd (10093632)
- Roles
- Exporter to the US
- First device listed
- June 14, 2025
- Registered through
- 2026
- Brand names listed
- Abrasive material Pulverized Corundum; Polishing Paste, Adhesive Tip Applicator; Optrastick, Binocular Loupe, Ceramic Etchant (HF-5 and HF-9), DUO,Aevra, Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series), FLNTScan R1;FLNTScan R1 Pro;FLNTScan R1 Cart;FLNTScan R2;FLNTScan R2 Pro;FLNTScan R2 Air;FLNTScan R2 Pod;FLNTScan R2 Car, Glaze Paster, Glaze Powder, and Glaze Liquid and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Exporter to the US | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Exporter to the US | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Exporter to the US | accessdata.fda.gov |
| External Cleaning Solution | PME | 2 | Exporter to the US | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Exporter to the US | accessdata.fda.gov |
| Loupe, Binocular, Low Power | HJH | 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 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 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 |
| October 2, 2024 | K240153 | Ceramic Etchant (HF-5 and HF-9) | KLE | 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 System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Powder, Porcelain
- All makers of Instruments, Dental Hand
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Loupe, Binocular, Low Power
- All makers of External Cleaning Solution
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.