FDA Registration
Active
🇪🇸 Spain
OPEN IMPLANTS
Reg #: 3008791019
·
FEI: 3008791019
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AVINENT IMPLANT SYSTEM S.L.U.
- Registration Number
- 3008791019
- FEI Number
- 3008791019
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Ctra. de Navarcles,107. Pol. Ind. santa Anna I.
- City
- Santpedor Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K212664
Owner / Operator
- Firm Name
- Avinent Implant System S.L.U.
- Operator Number
- 10046021
- Address
- Pol. Ind. Santa Ana I
- City
- Santpedor
- State
- Barcelona
- Postal Code
- 08251
- Country
- ES
- Correspondent
- Albert Giralt
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2024-11-22 |
Proprietary Names
OPEN IMPLANTS
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)