BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FX4810MLC

    Reg #: 3005503242 · FEI: 3005503242 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Dentium USA
    Registration Number
    3005503242
    FEI Number
    3005503242
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6761 Katella Ave.
    City
    CYPRESS
    State
    CA
    ZIP
    90630
    Country
    US

    Regulatory Submissions

    510(k) Number
    K041368

    Owner / Operator

    Firm Name
    Dentium USA
    Operator Number
    9063757
    Address
    6731
    City
    Cypress
    State
    CA
    Postal Code
    90630
    Country
    US

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    FX4810MLC FX3810MLC FX4314MLC FX3808MLC FX4808MLC FX3414MLC FX3812MLC FX4310MLC FX3410MLC FX3814MLC RAB45GN RAB45GH FX4812MLC FX4312MLC FX4814MLC FX3408MLC RAB45GNT FX4308MLC FX3412MLC

    Establishment Types

    Manufacture Medical Device