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510(k) Data Aggregation

    K Number
    K221488
    Device Name
    Z7 Zirconia Implant System
    Manufacturer
    Date Cleared
    2023-06-26

    (399 days)

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

    Z7 LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Z7 Zirconia Implant System is intended for surgical placement in the patient's upper and lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. The ø3.7 mm reduced diameter implants are recommended for central and lateral incisors only.
    Device Description
    The Z7 Zirconia Implant System is an integrated system of endosseous dental implants (Z7 Zirconia Implant One Piece) and PEEK prosthetic parts. The Z7 Zirconia Implant One Piece are yttria stabilized tetragonal zirconia (Y-TZP) dental implants composed of a One Piece, monotype implant with an integrated abutment. The implant is manufactured via a ceramic injection molding with the macro and micro surface characteristics of the implant directly structured in the mold. The implant body portion is configured to extend into the bone and osseo-integrate with the alveolar bone. The neck should be positioned 1.8mm above the bone. The implants come in corresponding diameters of 3.7 and 4.3 mm.
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