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510(k) Data Aggregation

    K Number
    K982201
    Device Name
    ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)
    Manufacturer
    FOREMOST DENTAL MFG., INC.
    Date Cleared
    1998-08-10

    (49 days)

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

    ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE)

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

    Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed.

    Device Description

    Not Found

    AI/ML Overview

    This appears to be a 510(k) clearance letter from the FDA for a dental core material, not a document describing a study for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not present in this document.

    The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, and does not involve performance studies against acceptance criteria in the way an AI/ML device would.

    Therefore, I cannot provide the requested table and study details.

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