FDA Registration
Active
🇺🇸 United States
Smartfit Final Hybrid Denture
Reg #: 3017450159
·
FEI: 3017450159
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HIOSSEN, INC.
- Registration Number
- 3017450159
- FEI Number
- 3017450159
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 56-58A East Bridge Street
- City
- Morrisville
- State
- PA
- ZIP
- 19067
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171585
Owner / Operator
- Firm Name
- Hiossen Inc.
- Operator Number
- 10026425
- Address
- 85 Ben Fairless Dr.
- City
- Fairless Hills
- State
- PA
- Postal Code
- 19030
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2025-03-24 |
Proprietary Names
Smartfit Final Hybrid Denture
Establishment Types
Manufacture Medical Device