Manufacturer registered with FDA
Liaoning Upcera Co., Ltd
Benxi, China. Lists 9 dental device types with FDA across 1 registered establishment, and holds 10 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 17
- 510(k) clearances
- 102014–2026
- Markets registered in
- 1183 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name Liaoning Upcera 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 | Manufacturer | Liaoning Upcera Co., Ltd | 10 clearances | 2014–2026 | Below |
| European Union | EUDAMED | Manufacturer | Liaoning Upcera Co Ltd | 18 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Liaoning Upcera Co.,Ltd.Liaoning Upcera Co., Ltd · Liaoning Upcera Co., Ltd. · +1 | 14 | 2011–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Liaoning Upcera Co Ltd | 11 | 2012–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Liaoning Upcera Co., Ltd.Liaoning Upcera Co., Ltd | 11 | 2013–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | LIAONING UPCERA CO., LTD. | 8 | 2016–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Liaoning Upcera Co Ltd | 6 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | LIAONING UPCERA CO., LTD | 5 | 2015–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Liaoning Upcera Co., Ltd. | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Liaoning Upcera Co., Ltd. | 3 | 2024–2024 | Pure Global AI |
| Japan | PMDA | Registration holder | Liaoning Upcera Co., Ltd. | 2 | 2023–2024 | 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 Liaoning Upcera 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 | Maker | Ceramic Etchant (HF-5 and HF-9)Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series)DUO,AevraGlaze Paste, Glaze Powder, and Glaze LiquidGradual Dental Zirconia BlankUpcera Coloring Liquid (I and II)Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2015 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Adhesive Tip ApplicatorOptrastick | 2023 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Hyramic CAD/CAM Restorative | 2017 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | PMMA Blocks, FLNT Temp, FLNT Base | 2026 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | PMMA Blocks, FLNT Temp, FLNT Base | 2026 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Abrasive material Pulverized CorundumPolishing Paste | 2023 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Ceramic Etchant (HF-5 and HF-9) | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | FLNTScan R1;FLNTScan R1 Pro;FLNTScan R1 Cart;FLNTScan R2;FLNTScan R2 Pro;FLNTScan R2 Air;FLNTScan R2 Pod;FLNTScan R2 Car | 2025 |
| External Cleaning SolutionPME · Class 2 | — | Maker | Ceramic Etchant (HF-5 and HF-9) | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Liaoning Upcera Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Mar 2026 | K253380 | FLNT Base and FLNT Temp | EBG Resin Temporary Crown and Bridge |
| 9 Jan 2026 | K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | EIH Porcelain Powder |
| 2 Oct 2024 | K240153 | Ceramic Etchant (HF-5 and HF-9) | KLE Resin Tooth Bonding Agent |
| 7 Sep 2023 | K231687 | Gradual Dental Zirconia Blank | EIH Porcelain Powder |
| 2 Sep 2018 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | EIH Porcelain Powder |
| 12 Jan 2017 | K162323 | Tooth Shade Resin Material | EBF Resin Tooth Shade Material |
| 4 Dec 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | EIH Porcelain Powder |
| 18 Dec 2014 | K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | EIH Porcelain Powder |
| 22 Oct 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | EIH Porcelain Powder |
| 22 Oct 2014 | K141723 | UPCERA COLORING LIQUID (I AND II ) | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Alien Milling Technologies (5), CAO Group, Inc. (3).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Liaoning Upcera Co.,LtdFDA reg. 3008254125 | Benxi Liaoning, China | Contract manufacturer, Foreign exporter, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031628). 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.