FDA Registration
Active
🇨🇳 China
SHENZHEN UPCERA DIGITAL DENTAL TECHNOLOGY CO., LTD
Reg #: 3039433962
·
FEI: 3039433962
·
Expires 2026
Products
10
Proprietary Names
14
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- SHENZHEN UPCERA DIGITAL DENTAL TECHNOLOGY CO., LTD
- Registration Number
- 3039433962
- FEI Number
- 3039433962
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Floor 5, R&D Building B, Tsinghua IT Port, No. 1 Xindong Road, Songping Shan Community, Xili Sub-District, Nan
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K181167
Owner / Operator
- Firm Name
- Shenzhen Upcera Digital Dental Technology Co., Ltd
- Operator Number
- 10093632
- Address
- Floor 5, R&D Building B, Tsinghua IT Port, No. 1 Xindong Road, Songping Shan Community, Xili Sub-District, Nan
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 117004
- Country
- CN
- Correspondent
- Li Luo
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2025-06-16 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2025-06-14 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2025-06-16 |
| External Cleaning Solution | PME | Class 2 | Dental | No | 2025-06-16 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2025-06-16 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2025-06-16 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2025-06-16 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2025-06-16 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2026-03-03 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2026-03-03 |
Proprietary Names
Adhesive Tip Applicator; Optrastick
Glaze Paster, Glaze Powder, and Glaze Liquid
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Binocular Loupe
Ceramic Etchant (HF-5 and HF-9)
Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series)
DUO,Aevra
Upcera Coloring Liquid (I and II)
Abrasive material Pulverized Corundum; Polishing Paste
Hyramic CAD/CAM Restorative
FLNTScan R1;FLNTScan R1 Pro;FLNTScan R1 Cart;FLNTScan R2;FLNTScan R2 Pro;FLNTScan R2 Air;FLNTScan R2 Pod;FLNTScan R2 Car
Gradual Dental Zirconia Blank
Upcera Dental Zirconia Blank for Aesthetic Restoration
PMMA Blocks, FLNT Temp, FLNT Base
Establishment Types
Export Device to the United States But Perform No Other Operation on Device