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510(k) Data Aggregation

    K Number
    K100247
    Device Name
    DETAX IMPLANTLINK SEMI
    Manufacturer
    DETAX GMBH & CO. KG
    Date Cleared
    2010-07-23

    (177 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DETAX IMPLANTLINK SEMI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DETAX implantlink® semi is designed for the temporary luting of implant-retained restorations. Requires no separating agents. Luted restorations can be removed. with standard devices (i.e. Crown Butler, Corona Fix).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental cement. The letter explicitly states it is a review of the notification and a determination of substantial equivalence.

    This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. It is a regulatory approval letter, not a study report.

    Therefore, I cannot fulfill your request for details on the acceptance criteria and the study that proves the device meets them based on the provided text.

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