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510(k) Data Aggregation

    K Number
    K242023
    Device Name
    Microdent Sterilization Cassette
    Date Cleared
    2025-02-19

    (223 days)

    Product Code
    Regulation Number
    880.6850
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    Applicant Name (Manufacturer) :

    Implant Microdent System S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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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    K Number
    K141188
    Device Name
    MICRODENT GENIUS IMPLANT SYSTEM
    Manufacturer
    Date Cleared
    2015-06-02

    (390 days)

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

    IMPLANT MICRODENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.
    Device Description
    Microdent Genius Implant System is comprised of dental implants and prosthetic components. Microdent Genius dental implants are internal connection endosseous implants machined titanium that can be used with deferred load or immediate load techniques. If sufficient bone depth is available the implant can be inserted sub-crestal. Microdent Genius Implant is recommended to place 2mm sub-crestal position. The implant has a connection formed by six grooves extending radially around the axis of the implant to provide a precise position of the abutment. Microdent Genius Implants are provided with blasted surface. The implants are supplied sterile and the abutments are provided non-sterile. Implants are also offered in various diameters and length. Contained various Microdent Genius abutments made of Ti-6AL 4-V-ELI alloy. The abutments Conical, Angled and Mini Capitel are used for cemented and screw-retained restorations. A Cover screw protects the inner configuration of the implant and supplied sterile with the implant. Healing abutment to shape the soft tissue during the healing phase. The Retention Screws are used for securing the abutments to the implant. Overdenture retention consists of a titanium alloy socket that attached to a threaded post for use with titanium endosseous implants having an internal threaded socket. Both devices have a plastic component that has a shape on one and that mate into the titanium socket, while the other end with metal cap is attached to the denture. All abutments include appropriate features and dimensions to mate with Microdent Genius implants.
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