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510(k) Data Aggregation

    K Number
    K020192
    Device Name
    SIMIDUR S2
    Date Cleared
    2002-03-15

    (52 days)

    Product Code
    Regulation Number
    872.3060
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIMIDUR S2

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

    Simidur S2 is a palladium-base ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Crowns, Short span bridges, Long span bridges, Removable partials and can be used for - Telescopic and milling work. Simidur S2 can be veneered with suitable dental ceramics as well as with dentalcomposites.

    Device Description

    Simidur S2 is a palladium-base ceramic alloy with a high content of noble metals (81% ), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two it has an indication which farges wortials. It is free of silver and suitable for telescopic and milling work. Simidur S2 is highly corrosion resistant and has an excellent biocompatibility. It fully Simidal U2 is highly ochooled ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. Simidur S2 can be veneered with suitable dental ceramics and with dental composites.

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving that the device meets those criteria. The provided text is a 510(k) summary for a dental alloy, Simidur S2, and the associated FDA clearance letter. It focuses on the device description, its indications for use, and its substantial equivalence to a legally marketed predicate device (Spartan Plus).

    Therefore, I cannot populate the requested table or answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria," as this information is not present in the provided text.

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