BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dentium USA

    Reg #: 3005503242 · FEI: 3005503242 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    79
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Dentium USA
    Registration Number
    3005503242
    FEI Number
    3005503242
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6761 Katella Ave.
    City
    CYPRESS
    State
    CA
    ZIP
    90630
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213599

    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
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    FXS7007C FXS4007BC FXS4507BC FXS4507C FXS6007C FXS5007C FXS3607BC FXS5007BC CMAB14NA CMAB30N CMAB15HAL CMAB10HAL CMAB15NA CMAB14HAL CMAB10NA CMAB30LH FX3814MLC FX4312MLC FX3812MLC FX4314MLC FX4308MLC FX3412MLC RAB45GNT FX4814MLC FX3810MLC FX3414MLC RAB45GN RAB45GH FX3410MLC FX4810MLC FX4808MLC FX4310MLC FX3408MLC FX3808MLC FX4812MLC FXS6010C FXS4510C FXS7012C FX4010SWC FXS5010C FXS3610C FXS6008C FX3614SWC FX4510SWC FX4008SWC FX4014SWC FXS4008C FXS7008C FXS4508C FX4512SWC FXS3608C FX7010SWC FX3608SWC FXS4514C FX4012SWC FXS4014C FX5008SWC FXS3612C FX5010SWC FXS3614C FX4508SWC FX6010SWC FX5012SWC FX4514SWC FX3612SWC FXS5012C FXS5008C FXS5014C FX7012SWC FXS4012C FXS7010C FX6012SWC FX6008SWC FX7008SWC FX3610SWC FX5014SWC FXS6012C FXS4512C FXS4010C

    Establishment Types

    Manufacture Medical Device