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510(k) Data Aggregation

    K Number
    K160596
    Device Name
    BEAUTIFIL II LS
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2016-07-27

    (147 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BEAUTIFIL II LS

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

    BEAUTIFIL II LS is a light-cured (400-500nm), radiopaque restorative material indicated for anterior and posterior restorations including occlusal surfaces.
    (Indications)
    · Anterior and posterior restorations
    · Repair of restorations and prostheses

    Device Description

    BEAUTIFIL II LS is a light-cured (400-500nm), radiopaque restorative material.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental resin material. It does not contain any information about acceptance criteria, device performance, study details, ground truth, or statistical analyses typically found in a scientific study or clinical trial report. Therefore, I cannot extract the requested information from this document.

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