BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ArgenZ Color Modifier

    Reg #: 3013551048 · FEI: 3013551048 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    The Argen Corporation
    Registration Number
    3013551048
    FEI Number
    3013551048
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8515 Miralani Drive
    City
    San Diego
    State
    CA
    ZIP
    92126
    Country
    US

    Regulatory Submissions

    510(k) Number
    K182833

    Owner / Operator

    Firm Name
    The Argen Corporation
    Operator Number
    9021799
    Address
    5855 Oberlin Drive, --
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Shilpi Sinha

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    ArgenZ Color Modifier ArgenZ Liquid Shade HT ArgenZ Liquid Shade ST ArgenZ Incisal Effect ArgenZ Pontic Reducer

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198