Registered with FDA
Shenzhen Upcera Dental Technology Co., Ltd
Shenzhen, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 313 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shenzhen Upcera Dental Technology 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 | Lister | Shenzhen Upcera Dental Technology Co., Ltd | 6 device types | — | Below |
| Brazil | ANVISA | Manufacturer | SHENZHEN UPCERA DENTAL TECHNOLOGY CO., LTD.Shenzhen Upcera Dental Technology Co., Ltd · SHENZHEN UPCERA DENTAL TECHNOLOGY CO. LTD | 12 | 2016–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHENZHEN UPCERA DENTAL TECHNOLOGY CO., LTD. | 1 | 2018–2018 | 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 Upcera Dental Technology 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 | Lister | Dental Zirconia Blank for Aesthetic RestorationDUO, AevraGlaze Paste, Glaze Powder, and Glaze LiquidGradual Dental Zirconia BlankUpcera Coloring Liquid (I and II)Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Adhesive Tip ApplicatorOptrastick | 2023 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Hyramic CAD/CAM Restorative | 2017 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | PMMA Blocks, FLNT Temp, FLNT Base | 2026 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | PMMA Blocks, FLNT Temp, FLNT Base | 2026 |
| Dental CementEMA · Class 2 | Dental cements | Lister | EnduraCem; EsCem | 2024 |
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 Upcera Dental Technology 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: Liaoning Upcera Co., Ltd (9).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Mar 2026 | K253380 | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd | EBG Resin Temporary Crown and Bridge |
| 9 Jan 2026 | K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 7 Sep 2023 | K231687 | Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 2 Sep 2018 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 12 Jan 2017 | K162323 | Tooth Shade Resin Material | Liaoning Upcera Co., Ltd | EBF Resin Tooth Shade Material |
| 4 Dec 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 18 Dec 2014 | K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 22 Oct 2014 | K141723 | UPCERA COLORING LIQUID (I AND II ) | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 22 Oct 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN UPCERA DENTAL TECHNOLOGY CO., LTDFDA reg. 3012441963 | Shenzhen Guangdong, China | Foreign exporter, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052091). 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.