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510(k) Data Aggregation

    K Number
    K223365
    Device Name
    RODIN Palette Naturalizing Kit
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2023-03-27

    (144 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RODIN Palette Naturalizing Kit

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

    Characterization of provisionals.

    Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
    Characterization of C&B composite resin restorations or acrylic resin.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the "RODIN Palette Naturalizing Kit" (K223365) does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The letter primarily focuses on the regulatory clearance of the device, confirming its substantial equivalence to predicate devices and outlining general regulatory requirements. It specifies the "Indications for Use" but does not delve into the technical study details that would typically be found in a submission's performance section.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided document.

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