LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993224
    Device Name
    T-GEAR, MODEL TG/400-700
    Manufacturer
    DONTECH PRODUCTS B.V.
    Date Cleared
    2000-02-11

    (137 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    DONTECH PRODUCTS B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient. This device is used to treat 'Overbite' and 'Overjet'.
    Device Description
    The T-Gear is a cervical headgear traction appliance that delivers constant forces on the dentition of an orthodontic patient.
    Ask a Question

    Page 1 of 1