Shenzhen Upcera Digital Dental Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 10 device types.
Shenzhen Upcera Digital Dental Technology Co., Ltd. is an exporter holding a current FDA establishment registration. The registration covers Powder, Porcelain, Instruments, Dental Hand and 8 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | SHENZHEN UPCERA DIGITAL DENTAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3039433962 |
| FEI number | 3039433962 |
| Establishment type | Exporter |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Floor 5, R&D Building B, Tsinghua IT Port, No. 1 Xindong Road, Songping Shan Community, Xili Sub-District, Nan |
| Postal code | 117004 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | Class 1 | Abrasive material Pulverized Corundum; Polishing Paste | 2025 | 25 |
| Agent, Tooth Bonding, Resin | Class 2 | Ceramic Etchant (HF-5 and HF-9) | 2025 | 6 |
| Crown And Bridge, Temporary, Resin | Class 2 | PMMA Blocks, FLNT Temp, FLNT Base | 2026 | 13 |
| External Cleaning Solution | Class 2 | Ceramic Etchant (HF-5 and HF-9) | 2025 | 3 |
| Instruments, Dental Hand | Class 1 | Adhesive Tip Applicator; Optrastick | 2025 | 64 |
| Loupe, Binocular, Low Power | Class 1 | Binocular Loupe | 2025 | 13 |
| Material, Tooth Shade, Resin | Class 2 | Hyramic CAD/CAM Restorative | 2025 | 10 |
| Powder, Porcelain | Class 2 | Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series), Ceramic Etchant (HF-5 and HF-9), Gradual Dental Zirconia Blank, Upcera Coloring Liquid (I and II), Upcera Dental Zirconia Blank for Aesthetic Restoration, Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank and 2 more | 2025 | 33 |
| Resin, Denture, Relining, Repairing, Rebasing | Class 2 | PMMA Blocks, FLNT Temp, FLNT Base | 2026 | 14 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Class 2 | FLNTScan R1;FLNTScan R1 Pro;FLNTScan R1 Cart;FLNTScan R2;FLNTScan R2 Pro;FLNTScan R2 Air;FLNTScan R2 Pod;FLNTScan R2 Car | 2025 | 36 |
Clearances
No clearance names Shenzhen Upcera Digital Dental Technology Co., Ltd. as applicant. 10 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K253380 | 2026-03-02 | EBG | Traditional | Liaoning Upcera Co., Ltd. |
| K253973 | 2026-01-09 | EIH | Special | Liaoning Upcera Co., Ltd. |
| K240153 | 2024-10-02 | KLE | Traditional | Liaoning Upcera Co., Ltd. |
| K231687 | 2023-09-07 | EIH | Traditional | Liaoning Upcera Co., Ltd. |
| K181167 | 2018-09-02 | EIH | Traditional | Liaoning Upcera Co., Ltd. |
| K162323 | 2017-01-12 | EBF | Traditional | Liaoning Upcera Co., Ltd. |
| K152175 | 2015-12-04 | EIH | Traditional | Liaoning Upcera Co., Ltd. |
| K141727 | 2014-12-18 | EIH | Traditional | Liaoning Upcera Co., Ltd. |
| K141723 | 2014-10-22 | EIH | Traditional | Liaoning Upcera Co., Ltd. |
| K141724 | 2014-10-22 | EIH | Traditional | Liaoning Upcera Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2001 |
|---|---|
| Main products | Dental ceramic zirconia, Lithium disilicate glass ceramics, CAD/CAM restoration systems, PMMA temporary materials, Digital dental solutions |
| Certifications | NMPA, CE, FDA, ISO 13485, MDR2017/745 |
| Export markets | 110+ countries and regions |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.