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510(k) Data Aggregation

    K Number
    K160086
    Device Name
    SHOFU Enamel Conditioner
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2016-07-21

    (188 days)

    Product Code
    EBF,KLE
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K082914
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Etching of natural enamel

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental product called "Shofu Enamel Conditioner." This letter does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) device evaluations.

    The document is a regulatory approval notice for a physical dental product (an enamel conditioner), not a software or AI-driven medical device. Therefore, the information requested in your prompt (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth methods) is not present in this type of document.

    The "Indications for Use" section (page 2) simply states "Etching of natural enamel" as the intended use of the product. No performance metrics or study details are provided.

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