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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
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving device performance for the "Evolux Cad/cam Pmma Blocks". The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, along with its indications for use. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

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