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510(k) Data Aggregation

    K Number
    K192153
    Device Name
    Portux CAD/CAM Disc
    Manufacturer
    New Stetic S.A.
    Date Cleared
    2019-11-07

    (90 days)

    Product Code
    EBG, EBI, MQC
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    New Stetic S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics. - Provisional anterior and posterior crowns & bridges - Implant and abutment supported prosthetics. - Partial, complete and hybrid denture prosthetics (base and teeth) Removable appliances (splint)
    Device Description
    The Subject device are discs made of poly methyl methacrylate (PMMA), a known material used in the dental field due their physical-chemical and biocompatibility properties. These discs are intended use with dental CAD/CAM equipment to produce a variety of provisional prosthetic restorations or devices. The discs are available in a variety of disc configurations to accommodate different commercial dental CAD/CAM machines fixture requirements. In addition, the CAD/CAM discs are available in a wide variety of heights and colors to facilitate matching of patient tooth or tissue shades.
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