BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GenTek

    Reg #: 3008932779 · FEI: 3008932779 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Zfx GmbH
    Registration Number
    3008932779
    FEI Number
    3008932779
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Kopernikusstr. 15
    City
    Dachau Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K231915

    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
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    GenTek

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility