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510(k) Data Aggregation

    K Number
    K063604
    Device Name
    TWINKY STAR NF
    Manufacturer
    VOCO GMBH
    Date Cleared
    2007-01-22

    (49 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Abbreviated
    Panel
    Dental
    Reference & Predicate Devices
    K994268,K003153,K053391,K974772
    Why did this record match?
    Device Name :

    TWINKY STAR NF

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

    Twinky Star NF is intended for fillings of deciduous teeth.

    Device Description

    Twinky Star NF is a light-curing, colored, radiopaque and fluoride containing compomer filling system for cavities of deciduous teeth.

    AI/ML Overview

    The provided document is a 510(k) summary for a dental filling material called "Twinky Star NF." It declares substantial equivalence to a predicate device and states its intended use. However, it does not contain any information about acceptance criteria, a specific study proving the device meets those criteria, or any performance metrics, sample sizes, or ground truth establishment relevant to the questions asked.

    The document primarily focuses on establishing substantial equivalence based on the technological characteristics and prior use of components in legally marketed devices, rather than presenting a performance study with acceptance criteria.

    Therefore, I cannot provide a detailed answer to your request based on the given input, as the information is not present in the document.

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