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510(k) Data Aggregation

    K Number
    K242023
    Device Name
    Microdent Sterilization Cassette
    Manufacturer
    Implant Microdent System S.L.U.
    Date Cleared
    2025-02-19

    (223 days)

    Product Code
    KCT
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Implant Microdent System S.L.U.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Microdent Sterlization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used. The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle: - Temperature: 270°F/132°C - Exposure time: 4 minutes. - Drying time: 20 minutes. - The cassettes are not to be stacked during sterilization. KTF and KBE references represent the worst case validated load due to the total weight of 509 grams and 220 grams respectively. Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette.
    Device Description
    Microdent Sterilization Cassette consists of different sizes of the same basic configuration (maximum weight 509 gr). All systems consist of a minimum of a plastic base and cover. Each cover can be fastened to its corresponding base by means of locking tab or guides. Accessories may be used with systems to organize or separate contents to be placed in them for use. The Delivery Systems are designed using plastic and metal materials that can be reused with steam sterilization methods. Each tray and cover have an evenly distributed hole pattern in relation to its size.
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