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510(k) Data Aggregation

    K Number
    K102973
    Device Name
    SILVER DENTAL ARREST
    Manufacturer
    COOLEY CONSULTING, INC.
    Date Cleared
    2014-07-31

    (1394 days)

    Product Code
    PHR
    Regulation Number
    872.3260
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SILVER DENTAL ARREST

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

    Treatment of Dental Hypersensitivity.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) premarket notification letter for "Silver Dental Arrest" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies for artificial intelligence or a medical device utilizing AI.

    The document is a regulatory approval letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include the detailed technical study data that would be necessary to answer your questions regarding acceptance criteria and device performance.

    Therefore, I cannot extract the requested information from the provided text.

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