Registered with FDA
Shenzhen Upcera Digital Dental Technology Co., Ltd
Shenzhen, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Shenzhen Upcera Digital 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 | Ceramic Etchant (HF-5 and HF-9)Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series)DUO,AevraGlaze Paster, Glaze Powder, and Glaze LiquidGradual Dental Zirconia BlankUpcera Coloring Liquid (I and II)Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankUpcera Dental Zirconia Blank for Aesthetic Restoration | 2025 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Adhesive Tip Applicator; Optrastick | 2025 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Hyramic CAD/CAM Restorative | 2025 |
| 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 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Abrasive material Pulverized Corundum; Polishing Paste | 2025 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | 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 | — | Lister | 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
Also lists devices cleared under other names
Shenzhen Upcera Digital 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 (10).
| 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 |
| 2 Oct 2024 | K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd | KLE Resin Tooth Bonding Agent |
| 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 DIGITAL DENTAL TECHNOLOGY CO., LTDFDA reg. 3039433962 | Shenzhen Guangdong, China | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10093632). 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.