BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KLOWEN BRACES DBA KLOWEN ORTHODONTICS

    Reg #: 3030265369 · FEI: 3030265369 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    KLOWEN BRACES DBA KLOWEN ORTHODONTICS
    Registration Number
    3030265369
    FEI Number
    3030265369
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1703 N. Plano Road, Ste. 200
    City
    Richardson
    State
    TX
    ZIP
    75081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251196

    Owner / Operator

    Firm Name
    KLOwen Braces dba KLOwen Orthodontics
    Operator Number
    10089784
    Address
    1703 N. Plano Road, Ste. 200
    City
    Richardson
    State
    TX
    Postal Code
    75081
    Country
    US
    Correspondent
    Tony Sapp

    Products

    Device Name Product Code
    Bracket, Plastic, Orthodontic DYW
    Indirect Bonding Tray QJJ

    Proprietary Names

    KLOwen Orthodontic Solution

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device