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510(k) Data Aggregation

    K Number
    K222604
    Device Name
    dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
    Manufacturer
    dentona AG
    Date Cleared
    2023-04-21

    (235 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    dentona AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dentona vivatemp and Dentona flexisplint (powder/liquid) are heat cured, moldable, acrylic compound systems for use in the fabrication of dental appliances such as splints, night guards, mouthquards and bruxism appliances. The optimill memosplint blank and the optimill memosplint version S blank are discs intended for the fabrication of dental appliances such as splints, night guards and bruxism appliances using CAD/CAM milling machines.
    Device Description
    Not Found
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