FDA Registration
Active
🇨🇳 China
HUNAN VSMILE BIOTECHNOLOGY CO.,LTD
Reg #: 3022068322
·
FEI: 3022068322
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- HUNAN VSMILE BIOTECHNOLOGY CO.,LTD
- Registration Number
- 3022068322
- FEI Number
- 3022068322
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building A4 No. 2450, Yuelu West Avenue,Changsha Hi-tech Development District
- City
- Changsha Hunan
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K141421
Owner / Operator
- Firm Name
- Hunan Vsmile Biotechnology Co.,Ltd
- Operator Number
- 10085833
- Address
- Building A4 No. 2450, Yuelu West Avenue, Changsha Hi-tech Development District
- City
- Changsha
- State
- Hunan
- Postal Code
- 410000
- Country
- CN
- Correspondent
- Xiaomi Tang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2022-12-13 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2022-12-13 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2022-12-13 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2022-12-13 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2022-12-13 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2025-06-25 |
Proprietary Names
Flexible Block
Removable resin
Dithilicate Glass Block
wax disc
Intraoral Scanner, VLS100
Dental Glass Ceramics Blocks (HT, LT, MT)
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device