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510(k) Data Aggregation

    K Number
    K231793
    Device Name
    RODIN 3D Resin SPLINT, Hard/Flex
    Manufacturer
    Belport Company, Inc., Gingi-Pak
    Date Cleared
    2024-03-26

    (280 days)

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

    RODIN 3D Resin SPLINT, Hard/Flex

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

    RODIN Splint is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, splints and repositioners.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental resin material, RODIN 3D Resin SPLINT, Hard/Flex. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML powered device.

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

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