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510(k) Data Aggregation

    K Number
    K190790
    Device Name
    Flex Fit
    Date Cleared
    2020-07-31

    (492 days)

    Product Code
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    DK Mungyo Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is indicated for the manufacturing of bases of partial or full removable dentures, occlusal splints and night guards through heating and pneumatic injection of the material, following the Instructions of Use that come with the product.
    Device Description
    FLEX FIT is a polyamide resin for non-clasp dentures. It is suitable for deep undercut cases, which need strength. The resin material has an inherent flexibility allowing for a strong yet flexible denture to be created. FLEX FIT (known as Bio Tone in attached test summaries) is a denture resin that is primarily based on polyamide. It is sold as a clear or pink colored, fine granular resin that is 1~2 mm3 in diameter. The resin is packaged in a re-sealable plastic containers. Using an injection-molding method, FLEX FIT polyamide resin can be effectively used to make various types of dentures that retain the highly flexible, yet durable characteristics. It is a highly effective material for making non-clasp dentures, partial prosthetic dentures, dental plates, denture bases, bite plates, personal trays, night guards, splints, etc. It uses thermal polymerization as its mode of polymerization. The FLEX FIT offers two colors: clear and pink.
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