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    K Number
    K220329
    Device Name
    G-CAM
    Manufacturer
    Graphenano Dental S.L.
    Date Cleared
    2022-08-16

    (193 days)

    Product Code
    EBFEBGEBI
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    Graphenano Dental S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    G-CAM discs are intended to be used for the manufacture of full and partial removable dentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, veneers, copings and substructures.
    Device Description
    G-CAM is a thermoplastic acrylic disc made by a principal base of polymethyl methacrylate (PMMA) resin doped with graphene (allotropic form of carbon), suitable for the creation of dental prostheses using CAD/CAM technology. G-CAM discs are intended to be used for the manufacture of full and partial removable dentures, implant overdentures as well as permanent and temporary restorations such as anterior or posterior crowns and bridges, inlays, onlays, veneers, copings and substructures.
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