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510(k) Data Aggregation

    K Number
    K220771
    Device Name
    Stratasys TrueDent
    Manufacturer
    Stratasys Ltd
    Date Cleared
    2022-07-07

    (113 days)

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

    Stratasys Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stratasys TrueDent™ is a light-curable resin indicated for the fabrication of dental appliances including removable full and partial dentures, denture bases, denture teeth, bridges, crowns, inlays, and veneers in dental laboratories. The material is an alternative to traditional heat-curable and auto polymerizing resins. Stratasys TrueDent™ is intended exclusively for professional dental work.
    Device Description
    Stratasys TrueDent™ is a light-curable methacrylate-based resin, that enables fabrication of monolithic, high quality, functional, and aesthetic dental appliances, including full and partial removable dentures, denture bases, denture teeth, bridges, crowns, inlays, onlays and veneers in a CAD/CAM additive manufacturing process. This material is intended to be used by trained dental professionals for the fabrication of various dental appliances in a CAD/CAM additive manufacturing process that includes the following components: digital dental files based on a digital impression, a Stratasys Poly Jet 3D printer, and curing light equipment. It is an alternative to traditional heat cured and auto polymerization resins. The predesigned color of the dental appliance is achieved by digitally mixing colored resins. The resins are available in five (5) different base colors (clear, white, cyan, magenta, and yellow). Stratasys TrueDent can be used only with Stratasys J5 Series printers. Stratasys J5 Series printers include a 3D printing system that utilizes PolyJet technology, with drop-on-demand inkjet printing process, 3 print heads, and a UV LED (395nm) curing process. The dental appliance is then cured in the Stratasys TrueDent™ Cure curing chamber and sent back to the dentist for try-in and final adjustment.
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