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510(k) Data Aggregation

    K Number
    K013277
    Device Name
    ASTRALIS 7, MODEL 557545
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2001-10-22

    (20 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K013077
    Why did this record match?
    Device Name :

    ASTRALIS 7, MODEL 557545

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

    Astralis 7 is a hand held polymerization unit used to cure dental composites

    Device Description

    Astralis 7 is a hand held polymerization unit

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth for the "Astralis 7" device.

    The document is a 510(k) premarket notification letter from the FDA to Ivoclar Vivadent, Incorporated, granting clearance for the "Astralis 7" as a "Ultraviolet Activator for Polymerization." It primarily addresses the legal and regulatory aspects of marketing the device, stating that it is substantially equivalent to legally marketed predicate devices. It also mentions general controls provisions of the Act that the manufacturer must comply with.

    The section titled "Indications For Use" simply states: "Astralis 7 is a hand held polymerization unit used to cure dental composites."

    Therefore, I cannot provide the requested table and study details as they are not present in the given text.

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