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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTOSIM, S.A. DE C.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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