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510(k) Data Aggregation

    K Number
    K050257
    Device Name
    LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
    Manufacturer
    MONDEAL MEDICAL SYSTEMS GMBH
    Date Cleared
    2005-02-07

    (4 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)

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

    The Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. The device is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding the Lin/Liou Orthodontic Mini Anchor System (LOMAS). This type of document establishes substantial equivalence to a predicate device and permits marketing. It does not contain information on acceptance criteria, a study proving device performance, or any of the detailed study parameters requested in your prompt.

    The letter is a regulatory approval document and not a scientific study report. Therefore, I cannot extract the requested information from the provided text.

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