LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K031752
    Device Name
    COLTOSOL F
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2003-08-05

    (61 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Temporary fillings of Class I and II cavities.

    Temporary sealing in endodontics.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets specific acceptance criteria.

    The document is a clearance letter from the FDA for a device called "Coltosol F." It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It also mentions the indications for use. However, it does not detail any performance metrics, studies, or acceptance criteria in the context of device performance.

    Therefore, I cannot provide the requested information.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1