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510(k) Data Aggregation

    K Number
    K193553
    Device Name
    VarseoSmile Temp
    Manufacturer
    BEGO Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG
    Date Cleared
    2020-05-18

    (150 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VarseoSmile Temp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VarseoSmile Temp resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral light-curing equipment.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental resin product ("VarseoSmile Temp"). It outlines the regulatory clearance status, general controls provisions, and indications for use of the device.

    However, it does not include any details about:

    • Acceptance criteria for device performance (beyond general regulatory compliance)
    • Specific "device performance" metrics or reported results
    • Sample sizes used for testing
    • Data provenance (country of origin, retrospective/prospective)
    • Number or qualifications of experts
    • Adjudication methods
    • Multi-reader multi-case (MRMC) studies
    • Standalone algorithm performance
    • Type of ground truth used
    • Training set sample size or how its ground truth was established

    The document primarily focuses on the administrative and regulatory aspects of the device's clearance.

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