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510(k) Data Aggregation

    K Number
    K050870
    Device Name
    RIVA LIGHT CURE
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2005-06-03

    (58 days)

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

    RIVA LIGHT CURE

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

    Minimal Class I, II and III restorations. Class V restorations, deciduous teeth and geriatric restorations, core build-ups, root surface restorations, used as a base or liner, pit and fissure sealant, semi-permanent fillings.

    Device Description

    Not Found

    AI/ML Overview

    This is a letter from the FDA regarding the 510(k) premarket notification for the Riva Light Cure dental cement. It states the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain acceptance criteria for the device's performance, nor does it describe any study. Therefore, I cannot provide the requested information.

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