LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982459
    Device Name
    TEMPFIL F - 2
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1998-09-30

    (77 days)

    Product Code
    EBG,EBU
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TempFil F - 2 is a light oured, single component temporary filling material intended l emplil F - Z is a light-successingle compensions in the go to be used for inlay and only preparations, implantserew-access openings andto be assurement of lost fillings for the emergency

    Device Description

    The device is a visible light-cured, single component temponery filling material. It is specifically designed for temporary inlays and onlays. TempFil F - 2 has a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily a 510(k) summary for a dental temporary restorative material called TempFil F-2. It describes the device, its intended use, and claims substantial equivalence to other legally marketed devices, but it does not detail any specific performance studies or acceptance criteria that would allow me to fill out the requested table and answer your questions.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1