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510(k) Data Aggregation

    K Number
    K102822
    Device Name
    IMPLANT-ONE SYSTEM
    Manufacturer
    CUSTOM DENTAL IMPLANTS INC
    Date Cleared
    2011-01-10

    (104 days)

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

    CUSTOM DENTAL IMPLANTS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Implant-One™ system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.
    Device Description
    The Implant-One™ Dental Implants include endosseous dental implants, cover screws, healing caps, dental implant abutments and abutment screws in a variety of sizes to accommodate differing patient anatomy. Endosseous implants are self-tapping, root-form and threaded. They range from 3.25mm to 5.5mm in diameter with lengths ranging from 8mm to 14mm and have an internal, threaded abutment connection having a Morse style taper. Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. Abutment options include Standard and Restorative in various heights. These are fastened to the implant using an abutment screw.
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