FDA Registration
Active
🇪🇸 Spain
Hex-Lock
Reg #: 3006411780
·
FEI: 3006411780
·
Expires 2025
Products
1
Proprietary Names
1
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
- K052600
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 |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2016-12-15 |
Proprietary Names
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Establishment Types
Complaint File Establishment per 21 CFR 820.198