BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FXS4514C

    Reg #: 3005503242 · FEI: 3005503242 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    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
    K160965

    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

    FXS4514C FX3608SWC FXS4510C FXS7008C FX4512SWC FX4514SWC FX3614SWC FX4510SWC FX5012SWC FX5014SWC FXS6012C FX4008SWC FX6010SWC FXS4508C FX5008SWC FXS5012C FXS3612C FX6012SWC FX6008SWC FXS5010C FXS4010C FXS4512C FXS4012C FXS4008C FX4012SWC FXS3610C FX5010SWC FXS3614C FX7008SWC FX4508SWC FXS5014C FX4010SWC FX3612SWC FXS6010C FX3610SWC FX4014SWC FXS6008C FXS7012C FXS7010C FXS4014C FX7010SWC FX7012SWC FXS5008C FXS3608C

    Establishment Types

    Manufacture Medical Device