FDA Registration
Active
🇳🇱 Netherlands
Temporary Prosthetic Screw
Reg #: 3006540014
·
FEI: 3006540014
·
Expires 2025
Products
1
Proprietary Names
4
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
- K202452
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 | 2020-12-04 |
Proprietary Names
Temporary Prosthetic Screw
NobelProcera Esthetic Implant Bridge Zirconia
NobelProcera Implant Bridge Zirconia
Clinical Screw Omnigrip (Mini)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device