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510(k) Data Aggregation

    K Number
    K233596
    Device Name
    VarseoSmile TriniQ
    Manufacturer
    BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
    Date Cleared
    2023-11-09

    (1 days)

    Product Code
    EBF, EBG, PZY
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    **BEGO Bremer Goldschlägerei Wilh. Herbst GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VarseoSmile TriniQ is indicated as an indirect restorative for both anterior restorations, including occlusal surfaces. The VarseoSmile TriniQ material is used for fabricating permanent restorations such as inlays, veneers, full crown and bridge restorations. VarseoSmile TriniQ can also be used for the fabrication of artificial teeth and temporary crowns & bridges.
    Device Description
    The Subject device is a light-cured methacrylate-based resin used in 3D printers to produce permanent or dental restorations such as crowns and bridges, inlays, onlays, veneers and full crown restorations including occlusal surfaces. The Subject device is used by a dental technician for the CAD/CAM manufacturing of temporary or permanent dental restorations. Restorations fabricated using the Subject device are one-time use, prescription-only devices. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration. Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties. The Subject device is intended to be sold by the bottle and used with compatible hardware in computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer, and post-cure unit.
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    K Number
    K201668
    Device Name
    VarseoSmile Crown plus
    Manufacturer
    BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
    Date Cleared
    2020-06-23

    (4 days)

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

    **BEGO Bremer Goldschlägerei Wilh. Herbst GmbH **& Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VarseoSmile Crown plus is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The VarseoSmile Crown Plus material is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.
    Device Description
    VarseoSmile Crown plus is a light-cured, methacrylate-based resin used in 3D printers for the production of permanent crowns, inlays, onlays and veneers. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of permanent dental restorations such as inlays, onlays, veneers and full crown prosthetics in compatible 3Dprinters. Restorations fabricated using the Subject device are one-time use, permanent, prescription-only devices. VarseoSmile Crown is suitable for restoration of occlusal surfaces. VarseoSmile Crown is cured externally to the patient by light sources within a 3D printer and post-curing device. The Subject device is a viscous solution consisting of methacrylate-based resins, dental glass filler, photo initiators and pigments. Commonly used dental CAD software is used by dental professionals to virtually design a fixed indirect restoration and generate an industry-standard "STL" 3D dataset which reflects the intended shape and contour. The Subject resin is used within a validated manufacturing workflow to create the intended restoration. The Subject device is available in a variety of optional shades to reproduce the intended tooth shade of the restoration.
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