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510(k) Data Aggregation

    K Number
    K170776
    Device Name
    DTI-1 SLA IMPLANT SYSTEM
    Manufacturer
    DTI Implant Sistemleri Sanayi Ticaret Anonim Sirketi
    Date Cleared
    2018-04-10

    (392 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DTI-1 SLA Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) clearance letter for the DTI-1 SLA Implant System, which confirms its substantial equivalence to a predicate device and outlines regulatory guidelines. It specifies the intended use of the device but does not detail any performance studies, acceptance criteria, or specific performance metrics. Therefore, I cannot extract the requested information.

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