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510(k) Data Aggregation

    K Number
    K173975
    Device Name
    UF(II) Wide Fixture
    Manufacturer
    DIO Corporation
    Date Cleared
    2018-06-01

    (154 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K063216,K122519
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The UF(II) Wide Fixture is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment's chewing function. The larger (Ø5.9 – Ø6.9mm) implants can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.

    Device Description

    UF(II) Wide Fixture is especially designed for use in dental implant surgery. It is intended to be surgically placed in the bone of the upper or lower jaw arches. It consists of titanium, screw-form, root-form endosseous dental implant.

    AI/ML Overview

    This document is a 510(k) summary for a dental implant device, not a study report for a medical AI device. Therefore, it does not contain the information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria for an AI device.

    The document discusses the substantial equivalence of the UF(II) Wide Fixture dental implant to predicate devices based on non-clinical tests like sterilization validation, shelf-life testing, fatigue testing, biocompatibility, and mechanical testing. It does not mention any AI component or studies related to AI performance.

    Therefore, I cannot provide the requested information.

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