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510(k) Data Aggregation

    K Number
    K120283
    Manufacturer
    Date Cleared
    2012-07-31

    (182 days)

    Product Code
    Regulation Number
    872.3275
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DIMER DUAL CURE PERMANENT/TEMPORARY RESIN CEMENT

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

    "Dimer Dual Cure Temporary Resin Cement" is indicated for the temporary cementation of provisional restorations such as crowns and Bridges, inlays and onlays, Maryland bridges, veneers or for the temporary cementation of permanent dental restorations.

    "Dimer Dual Cure Permanent Resin Cement" is indicated for the final cementation of implant prostheses, crowns and bridges, inlays and onlays, Maryland bridges, veneers, pins and posts and also periodontal splinting.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a dental cement. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

    The document primarily focuses on:

    • Acknowledging the 510(k) submission for "Dimer Dual Cure Permanent Resin Cement" and "Dimer Dual Cure Temporary Resin Cement."
    • Stating that the device is substantially equivalent to legally marketed predicate devices.
    • Outlining the general controls and regulations applicable to the device.
    • Providing the Indications for Use for both permanent and temporary resin cements.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study from this document, as that information is not present.

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