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510(k) Data Aggregation

    K Number
    K182065
    Device Name
    EVOLUX CAD/CAM PMMA BLOCKS
    Manufacturer
    Blue Dent Dental
    Date Cleared
    2018-12-13

    (134 days)

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

    Blue Dent Dental

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology. Indications: - Temporary anterior and posterior crowns - Temporary anterior and posterior bridges with up to two adjacent pontics - Implant supported temporary restorations - Maximum recommended usage period: 12 months - Removable structures for dentures (dental bases) - Removable structures for therapeutic restorations (bite splints or occlusal splints)
    Device Description
    Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.
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