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510(k) Data Aggregation

    K Number
    K972355
    Device Name
    3M AURORA SYSTEM
    Manufacturer
    3M COMPANY
    Date Cleared
    1997-08-29

    (65 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The 3M™ Aurora System is indicated to activate a photochemical polymerization reaction in light cure dental materials.

    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 the device meets those criteria. The document is an FDA letter acknowledging a 510(k) submission for the "3M Aurora System" and stating that the device is substantially equivalent to previously marketed devices. It also includes the indications for use.

    Therefore, I cannot extract any of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods from this document.

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