FDA Registration
Active
🇳🇱 Netherlands
Procera Abutments Branemark System Zirconia
Reg #: 3006540014
·
FEI: 3006540014
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- NOBEL BIOCARE DISTRIBUTION CENTER BV
- Registration Number
- 3006540014
- FEI Number
- 3006540014
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Popeweg 72
- City
- Venlo Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K031719
Owner / Operator
- Firm Name
- Nobel Biocare Services AG
- Operator Number
- 8030879
- Address
- Balz-Zimmermann-Strasse 7
- City
- Kloten
- State
- Zurich
- Postal Code
- 8302
- Country
- CH
- Correspondent
- Valeria Barbarito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2009-08-03 |
Proprietary Names
Procera Abutments Branemark System Zirconia
Procera Abutments NobelReplace Zirconia
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device