FDA Registration
Active
🇨🇳 China
Dental crown, PFM crown, Full metal crown, Implant crown, Acrylic denture
Reg #: 3030233416
·
FEI: 3030233416
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- FOTIS DENTAL LAB (HK) CO., LIMITED
- Registration Number
- 3030233416
- FEI Number
- 3030233416
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- UNIT 917A, 9/F., TOWER A, NEW MANDARIN PLAZA, NO.14 SCIENCE MUSEUM ROAD, TSIMSHATSUI, KOWLOON
- City
- HONG KONG
- Country
- CN
Owner / Operator
- Firm Name
- FOTIS DENTAL LAB (HK) CO., LIMITED
- Operator Number
- 10089294
- Address
- UNIT 917A, 9/F., TOWER A, NEW MANDARIN PLAZA, NO.14 SCIENCE MUSEUM ROAD, TSIMSHATSUI, KOWLOON
- City
- HONG KONG
- State
- CN-NOTA
- Postal Code
- 999077
- Country
- CN
- Correspondent
- Bruce Li
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2023-11-27 |
Proprietary Names
Dental crown, PFM crown, Full metal crown, Implant crown, Acrylic denture
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device