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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    T-GEAR, MODEL TG/400-700

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "T-Gear", which is a cervical headgear traction appliance.

    While it indicates the device is substantially equivalent to legally marketed predicate devices and states its indications for use, it does not include:

    • A table of acceptance criteria or reported device performance.
    • Information on sample sizes, data provenance, or ground truth establishment for any test or training sets.
    • Details about expert qualifications, adjudication methods, or MRMC studies.
    • Results from standalone algorithm performance.

    The letter is primarily a regulatory approval document confirming market clearance based on substantial equivalence, rather than a technical report detailing a performance study.

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