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510(k) Data Aggregation

    K Number
    K220743
    Device Name
    CediTEC
    Manufacturer
    VOCO GmbH
    Date Cleared
    2022-07-05

    (113 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CediTEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Luting of prefabricated prosthetic teeth and CAD/CAM-produced individual teeth and tooth sections in CAD/CAMproduced denture bases
    • Luting of prosthetic teeth in the scope of a repair or extension
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental resin called CediTEC. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is primarily administrative, confirming that the device is substantially equivalent to legally marketed predicate devices and outlining regulatory requirements.

    Therefore, I cannot provide the requested information based on the provided text.

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