BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Full OSSEOTITE Implant

    Reg #: 3006411780 · FEI: 3006411780 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    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
    K063286

    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
    [email protected]
    Phone
    561 7766700

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    Full OSSEOTITE Implant OSSEOTITE XP Miniplant Cover Screw Headless Cover Screw Implant OSSEOTITE Tapered Implant NanoTite Implant Implant Cover Screw NanoTite Tapered Implant Full OSSEOTITE XP Miniplant LTX Implant Full OSSEOTITE Tapered Implant OSSEOTITE Implant LTX XP Miniplant OSSEOTITE XP Implant

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198