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510(k) Data Aggregation

    K Number
    K092507
    Device Name
    ZIT-Z
    Manufacturer
    Date Cleared
    2010-05-11

    (267 days)

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

    ZITERION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading. The 3.5mm implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upper jaw.
    Device Description
    Zit-z Dental Implant System is a root-form dental implant system with a one-piece cylindrical screw implant design. They have a pentagonal geometry anti-rotation feature which also provides ease of insertion. They are made from HIP zirconium dioxide ceramics (3Y-TZP) which meets (SO 13356.
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