Data / Medical devices / United States / Upcera Dental America Inc.
Upcera Dental America Inc.: FDA-registered device maker in Cerritos, CA, United States, 8 510(k) clearances
Upcera Dental America Inc. is registered with the FDA (registration 3019596325) in Cerritos, CA, United States. It lists 4 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 5, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3019596325
- Address
- 13100 Alondra Blvd. Ste. 105, Cerritos, CA, United States, 90703
- Owner or operator
- Upcera Dental America Inc. (10082186)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- December 25, 2021
- Registered through
- 2026
- Brand names listed
- Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series), Glaze Paste, Glaze Powder, and Glaze Liquid, Hyramic CAD/CAM Restorative, POWDER, PORCELAIN, Upcera Coloring Liquid (I and II), Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Wax Block
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 5, 2025 | K251084 | zirkon; structure; LFU shades, stains and glazes | EIH | Substantially Equivalent | Estetic Ceram AG | 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 |
| February 9, 2015 | K141421 | PMMA BLOCK | EBG | Substantially Equivalent | Rizhao Huge Dental Industry 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 Powder, Porcelain
- All makers of Material, Tooth Shade, Resin
- All makers of Wax, Dental, Intraoral
- All makers of Crown And Bridge, Temporary, Resin
Updated June 5, 2025. 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.