FDA Registration
Active
🇨🇳 China
SHENZHEN UPCERA DENTAL TECHNOLOGY CO., LTD
Reg #: 3012441963
·
FEI: 3012441963
·
Expires 2026
Products
6
Proprietary Names
11
Establishment Types
2
Classifications
6
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Registration Details
- Registration Name
- SHENZHEN UPCERA DENTAL TECHNOLOGY CO., LTD
- Registration Number
- 3012441963
- FEI Number
- 3012441963
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2nd Floor, Tsinghua IT Port B, High-tech Park, Nanshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K253380
Owner / Operator
- Firm Name
- Shenzhen Upcera Dental Technology Co., Ltd
- Operator Number
- 10052091
- Address
- Floor 5,R&D Building B, Tsinghua IT Port,No.1 Xindong Road,Songping Shan Community,, Xili Sub-District, Nanshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518057
- Country
- CN
- Correspondent
- Li Luo
US Agent
- Business Name
- Manton Business and Technology Services
- Contact Name
- Charles Shen
- Address
- 37 Winding Rdg
- City
- Oakland
- State
- NJ
- ZIP
- 07436
- Country
- US
- [email protected]
- Phone
- 608 2179358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| 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 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2016-06-12 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2017-12-12 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2023-01-10 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2024-03-17 |
Proprietary Names
PMMA Blocks, FLNT Temp, FLNT Base
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Hyramic CAD/CAM Restorative
Glaze Paste, Glaze Powder, and Glaze Liquid
Gradual Dental Zirconia Blank
Dental Zirconia Blank for Aesthetic Restoration
Upcera Coloring Liquid (I and II)
Adhesive Tip Applicator
Optrastick
EnduraCem; EsCem
DUO, Aevra
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Foreign Private Label Distributor