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510(k) Data Aggregation

    K Number
    K161630
    Device Name
    Provicol QM Plus
    Manufacturer
    VOCO GMBH
    Date Cleared
    2016-09-15

    (94 days)

    Product Code
    EMB
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Provicol QM Plus

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

    Provicol QM Plus is intended for use as:

    • · Temporary cementation of provisional restorations (crowns, bridges, inlays and onlays)
    • . Temporary cementation of definitive restorations (crowns, bridges, inlays and onlays)
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is an FDA letter regarding a 510(k) premarket notification for a dental cement called "Provicol QM Plus." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements for the manufacturer. It also includes the indications for use statement for the device.

    Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, study types, or ground truth details, as this information is not present in the given text.

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