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510(k) Data Aggregation

    K Number
    K221022
    Device Name
    NextDent Ortho Flex
    Manufacturer
    Vertex-Dental BV
    Date Cleared
    2022-10-21

    (198 days)

    Product Code
    MQC, KMY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vertex-Dental BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NextDent Ortho Flex is a 3D print resin intended for the manufacturing of 3D printed dental splints and retainers. To retain the regulated dentition. NextDent Ortho Flex is intended exclusively for professional dental work.
    Device Description
    Light-Cure Resin, provided in a container. NextDent Ortho Flex is a dimethacrylic based light-cure resin with pigments, polymerized via photo initiators in a 3D printer setting for fabrication of splints and retainers for long term repeated use. Fabrication of splints and retainers with NextDent Ortho Flex requires a computer-aided and manufacturing (CAD/CAM) system that includes the following additive printer and post-cure unit: Printer: Brand: 3D Systems, Type: NextDent 5100 Figure 4, Software: 3D Sprint Post-cure unit: Brand: NextDent, Type: LC-3DPrint Box, Software: n.a. Printer and resin must be optimized to each other in order to get complete and precise printed parts. Both the NextDent™5100 Figure4® 3D printer and the post-curing lightbox NextDent™ LC-3DPrint Box make use of a UV light source to polymerize the NextDent Ortho Flex resin. NextDent™5100 Figure4® 3D printer or NextDent™ LC-3DPrint Box is not included with the device. Cured parts are finished using conventional dental methods and instruments. NextDent 3D printed cured parts should be cleaned with nonchemical products. Materials of Use: dimethacrylate-based resins with photo-initiator and pigments.
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    K Number
    K191497
    Device Name
    NextDent Denture 3D+
    Manufacturer
    Vertex-Dental BV
    Date Cleared
    2019-11-01

    (149 days)

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

    Vertex-Dental BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NextDent Denture 3D+ is a light-cured resin indicated for the fabrication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent Denture 3D+ is intended exclusively for professional dental work. Fabrication of denture bases with NextDent Denture 3D+ requires a computer-aided and manufacturing (CAD/CAM) system that includes the following scanner, design software, additive printer and post-cure unit:
    Device Description
    Light-Cure Resin, provided in a container. NextDent Denture 3D+ dimethacrylic system, polymerized via photo initiators in a 3D printer setting. The color of the denture is determined by the addition of pigments. NextDent™ Denture 3D+ must be used in combination with the NextDent™ 5100 Figure4® 3D printer. Printer and resin must be optimized to each other in order to get complete and precise printed parts. If printer and resin are not optimized to each other this may have an adverse effect on the accuracy and physical quality of printed parts. The NextDent™ 5100 Figure4® 3D printer and the post-curing lightbox NextDent™ LC-PrintBox make use of a light source to polymerize the NextDent resin.
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    K Number
    K162572
    Device Name
    NextDent Denture, E-Denture
    Manufacturer
    VERTEX-DENTAL BV
    Date Cleared
    2017-06-30

    (288 days)

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

    VERTEX-DENTAL BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NextDent™ Denture / E-Denture is a light-cured resin indication of denture bases fabricated in dental laboratories, including full and partial removable dentures. The material is an alternative to traditional heat cured and auto polymerization resins. NextDent ™ Denture is intended exclusively for professional dental work. Fabrication of denture bases with NextDent ™ Denture / E-Denture requires a computer-aided and manufacturing (CAD/CAM) system that includes the following: scanner, design software, additive printer and post-cure unt.
    Device Description
    NextDent™ Denture / E-Denture 3D-printing material is a light-cured resin indicated for the manufacturing of denture bases. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization.
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