BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Premium

    Reg #: 3006610834 · FEI: 3006610834 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KULZER GMBH
    Registration Number
    3006610834
    FEI Number
    3006610834
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SchlatterstraBe 2
    City
    WASSERBURG Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K011130

    Owner / Operator

    Firm Name
    KULZER, LLC
    Operator Number
    9056636
    Address
    4315 S. Lafayette Blvd.
    City
    South Bend
    State
    IN
    Postal Code
    46614
    Country
    US
    Correspondent
    David A Vincent

    US Agent

    Business Name
    Kulzer, LLC
    Contact Name
    David Vincent
    Address
    4315 S. Lafayette Blvd
    City
    South Bend
    State
    IN
    ZIP
    46614
    Country
    US
    Email
    [email protected]
    Phone
    574 2995421

    Products

    Device Name Product Code
    Denture, Plastic, Teeth ELM

    Proprietary Names

    Premium

    Establishment Types

    Manufacture Medical Device