FDA Registration
Active
🇨🇳 China
Liaoning Upcera Co.,Ltd
Reg #: 3008254125
·
FEI: 3008254125
·
Expires 2026
Products
10
Proprietary Names
15
Establishment Types
4
Classifications
10
Registration Details
- Registration Name
- Liaoning Upcera Co.,Ltd
- Registration Number
- 3008254125
- FEI Number
- 3008254125
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.122 Xianghuai Road, Economic Development Zone
- City
- Benxi Liaoning
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K253380
Owner / Operator
- Firm Name
- Liaoning Upcera Co., Ltd
- Operator Number
- 10031628
- Address
- NO.122 Xianghuai Road, Economic Development Zone
- City
- Benxi
- State
- Liaoning
- Postal Code
- 117004
- 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 |
|---|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2023-07-21 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2025-05-26 |
| 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 | 2015-01-04 |
| Loupe, Binocular, Low Power | HJH | Class 1 | Ophthalmic | No | 2024-11-29 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2025-01-08 |
| External Cleaning Solution | PME | Class 2 | Dental | No | 2025-01-08 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2023-01-10 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2017-11-21 |
Proprietary Names
Polishing Paste
Abrasive material Pulverized Corundum
FLNTScan R1;FLNTScan R1 Pro;FLNTScan R1 Cart;FLNTScan R2;FLNTScan R2 Pro;FLNTScan R2 Air;FLNTScan R2 Pod;FLNTScan R2 Car
PMMA Blocks, FLNT Temp, FLNT Base
Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series)
Binocular Loupe
Ceramic Etchant (HF-5 and HF-9)
Adhesive Tip Applicator
Optrastick
Gradual Dental Zirconia Blank
Hyramic CAD/CAM Restorative
Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Glaze Paste, Glaze Powder, and Glaze Liquid
DUO,Aevra
Upcera Coloring Liquid (I and II)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device