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510(k) Data Aggregation

    K Number
    K050013
    Device Name
    RETRACTOFOAM
    Manufacturer
    COLTENE/WHALEDENT AG
    Date Cleared
    2005-02-09

    (37 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RETRACTOFOAM

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

    For the temporary opening/widening of the sulcus.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set details for the RetractoFoam device.

    The document is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG regarding the RetractoFoam device. It states that the FDA has reviewed the submission and determined the device to be substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications and general controls but does not include details of any performance studies.

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