BEUDAMED
    FDA Registration Active 🇪🇸 Spain

    Certain Flat Implant Cover Screw

    Reg #: 3009840806 · FEI: 3009840806 · 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
    3009840806
    FEI Number
    3009840806
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    c/Islas Baleares, 50, Pol. Ind. Fuente del Jarro
    City
    Paterna Valencia
    Country
    ES

    Regulatory Submissions

    510(k) Number
    K063341

    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

    Certain Flat Implant Cover Screw Certain PREVAIL Implant OSSEOTITE XP Certain Implant Certain Implant Headless Cover Screw Full OSSEOTITE Certain Implant Full OSSEOTITE Tapered Certain Implant Certain MicroMini Flat Implant Cover Screw Certain Implant Cover Screw OSSEOTITE Tapered Certain Implant Certain Cover Screw Full OSSEOTITE XP Certain Implant NanoTite Tapered Certain Implant Certain Implant Straight Cover Screw OSSEOTITE Certain Implant

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)