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510(k) Data Aggregation

    K Number
    K172407
    Device Name
    Duracetal
    Manufacturer
    The Myerson Company Limited
    Date Cleared
    2017-11-02

    (85 days)

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

    The Myerson Company Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.
    Device Description
    The product is a thermoplastic dental resin intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. The material is an acetal thermoplastic resin. The pellet version of the resin are melted and reshaped to form the dental device. The disc version of the material is milled to form the dental device.
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