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510(k) Data Aggregation

    K Number
    K230098
    Device Name
    Trusana™
    Manufacturer
    Date Cleared
    2023-04-13

    (90 days)

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

    Myerson, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.
    Device Description
    The Trusana device is a light-activated denture base resin, offered in four shades. The Trusana resin is used with patient-specific *.stl files provided by the dental practitioner to fabricate the customized denture bases for removable denture devices using a 3D (additive) printer and curing unit. The proprietary light-curable resin is composed of methylacrylated monomers, methacrylated carboxylic acid, phosphine oxide initiator and pigments for color It is used by dental laboratories and dental practices to make the denture bases for the removable dentures. The resin is offered in lightproof 1L high density polyethylene (HDPE) bottles. Trusana resin is an alternative material to heat-curable and auto-polymerizable resins.
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