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510(k) Data Aggregation

    K Number
    K032392
    Device Name
    MORALES PROTRACTION FACEMASK
    Manufacturer
    ORTOSIM, S.A. DE C.V.
    Date Cleared
    2003-10-22

    (79 days)

    Product Code
    DZB
    Regulation Number
    872.5500
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTOSIM, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Morales Protraction Facemask is intended as an efficient extraoral appliance in moving skeletal Class III maxilla forward and stabilizing or retracting the mandible. It is also effective in closing space and correcting negative overjet.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, sample size, ground truth establishment, or any studies conducted for the Morales Protraction Facemask. The document is an FDA 510(k) premarket notification letter, which primarily focuses on the substantial equivalence of the device to legally marketed predicate devices and administrative details like regulation numbers and contact information. It does not contain the detailed technical or clinical study data you are asking for.

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