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    K Number
    K993783
    Device Name
    TETRIC FLOW
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1999-12-13

    (35 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TETRIC FLOW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Class V restorations (cervical caries, root erosion, wedge shaped defects)
    • Anterior restorations (Class III and IV)
    • Small posterior restorations
    • Restorative therapy for mini-cavities, of all types (preparation with Sonic-Sys Micro Instruments from KaVo)
    • Adhesive cementation of Sonic-Sys Inlays
    • Extended fissures sealings in molars and pre-molars
    • Repair of composite/ceramic veneers
    • Blocking out of undercuts
    • Adhesive cementation of ceramic and composite restorations
    Device Description

    Light activated hybrid composite

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a clearance letter from the FDA for a dental composite called "Light activated hybrid composite" (Trade Name: Tetric Flow), indicating it is substantially equivalent to existing devices and can be marketed.

    Therefore, I cannot fulfill your request for the detailed table and study information as it is not present in the given text.

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