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510(k) Data Aggregation

    K Number
    K190453
    Device Name
    VisCalor bulk
    Manufacturer
    VOCO GmbH
    Date Cleared
    2019-04-11

    (45 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K012345,K987654
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    _DEN123456, K012345, K987654

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Class I and II posterior restorations
    • Base in class I and II cavities
    • Class V restorations
    • Locking, splinting of loose teeth
    • Repairing veneers, enamel defects and temporary C&B-materials
    • Extended fissure sealing
    • Restoration of deciduous teeth
    • Core build-up
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter for a dental device called VisCalor Bulk. It contains information related to the device's indications for use and regulatory classification. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    Therefore, I cannot provide the requested information. The text is a regulatory document and not a clinical study report or technical specification document detailing performance metrics.

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