BEUDAMED
    FDA Registration Active 🇨🇳 China

    MONDIAL

    Reg #: 3005431169 · FEI: 3005431169 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KULZER DENTAL LTD.
    Registration Number
    3005431169
    FEI Number
    3005431169
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO. 1585 GUMEI ROAD
    City
    SHANGHAI
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K060994

    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

    MONDIAL Mondial I

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)