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510(k) Data Aggregation

    K Number
    K962442
    Device Name
    HYTAC APLITIP/HYTAC OSB
    Manufacturer
    ESPE GMBH & CO. KG.
    Date Cleared
    1996-09-11

    (79 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K900510,K904289,K951836
    Why did this record match?
    Device Name :

    HYTAC APLITIP/HYTAC OSB

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

    Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.

    Device Description

    Hytac® Aplitip® is a compomer filling material. Hytac® OSB is a light cured bonding agent.

    AI/ML Overview

    This appears to be a 510(k) summary for a dental filling material and bone agent, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, ground truth, and expert involvement is not applicable in the context of AI/ML performance evaluation.

    The document discusses substantial equivalence to predicate devices based on physical and technical characteristics, ingredient composition, and biological safety tests (cytotoxicity, Ames, skin irritation, eye irritation, acute oral toxicity, and sensitization). It also states that the products meet relevant DIN and ISO standards for dental composite material. However, these are not the "acceptance criteria" and "study" as one would describe for an AI/ML device's performance metrics (e.g., sensitivity, specificity, AUC).

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