FDA Registration
Active
🇪🇸 Spain
3i T3 Non-Platform Switched Parallel Walled Implant
Reg #: 3006411780
·
FEI: 3006411780
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Biomet 3i Dental Iberica S.L.U.
- Registration Number
- 3006411780
- FEI Number
- 3006411780
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- WTC Almeda Park, Ed.4, Planta 2, C/Tirso de Molina, 40
- City
- Cornella de Llobregat Barcelona
- Country
- ES
Regulatory Submissions
- 510(k) Number
- K122300
Owner / Operator
- Firm Name
- Biomet 3i
- Operator Number
- 1038806
- Address
- 4555 Riverside Drive, --
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
- Correspondent
- Ruth Lopez
US Agent
- Business Name
- BIOMET 3I
- Contact Name
- Henrique Nomelini Muniz
- Address
- Palm Beach Gardens, 4555 Riverside Drive
- City
- Palm Beach Gardens
- State
- FL
- ZIP
- 33410
- Country
- US
- [email protected]
- Phone
- 561 7766700
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-01-31 |
Proprietary Names
3i T3 Non-Platform Switched Parallel Walled Implant
3i T3 Tapered Implant
3i T3 with DCD Non-Platform Switched Tapered Implant
3i T3 Non-Platform Switched Tapered Implant
3i T3 with DCD Non-Platform Switched Parallel Walled Implant
3i T3 with DCD Parallel Walled Implant
3i T3 Parallel Walled Implant
3i T3 with DCD Tapered Implant
Establishment Types
Complaint File Establishment per 21 CFR 820.198