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510(k) Data Aggregation

    K Number
    K110392
    Device Name
    PSM LOMAS / BENEFIT SCREWS
    Manufacturer
    PSM MEDICAL SOLUTIONS
    Date Cleared
    2011-12-14

    (306 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    PSM MEDICAL SOLUTIONS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PSM LOMAS / BENEFIT Screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. Screws are intended for single use only.
    Device Description
    The PSM LOMAS / BENEFIT Screws are made of Titanium alloy. The bone screws are designed to be used transmucosally for osseous orthodontic anchorage. They are used as Temporary Anchorage Devices (TAD) for orthodontic treatments. The LOMAS screws (Ø1.5 mm and 2.0 mm), as well as the BENEFIT screws (Ø2.0mm and 2.3mm) come in two diameters and all screws come in five lengths (7 mm, 9 mm, 11 mm, 13 mm, and 15 mm). The screws are divided in five groups of screws, LOMAS Standard, LOMAS Quattro, LOMAS Quattro V and BENEFIT Screws. The range of providing flexibility for specific orthodontic applications. The screws consist of either three or four components: head, platform, body (thread) or moreover neck.
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