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510(k) Data Aggregation

    K Number
    K132141
    Device Name
    BEAUTIFIL BULK FLOWABLE
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2013-10-03

    (84 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • . Base in Class I and II direct restorations
    • . Liner under direct restorative materials
    • . Restorations of small posterior cavities (including occlusal restorations)
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a dental resin material (Beautifil Bulk Flowable). This document outlines the FDA's marketing clearance for the device based on its substantial equivalence to a predicate device.

    This document does NOT contain information about acceptance criteria, detailed device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt.

    Therefore, I cannot extract the information necessary to fulfill your request. The document discusses regulatory aspects, product classification, and indications for use, but not the specific technical study details you are looking for.

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