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510(k) Data Aggregation

    K Number
    K132748
    Device Name
    BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2013-12-04

    (92 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

    BEAUTIFIL e Posterior / BEAUTIFIL Bulk comes in 28 shades, among which Universal and A shade (given the trade name BEAUTIFIL Bulk) provide high transparency and greater depth of cure by reducing pigment content compared to other shades. Universal and A shade (BEAUTIFIL Bulk) are intended only for direct posterior restorations.

    BEAUTIFIL e Posterior
    (Indications)

    • Direct posterior restorations .
    • Repair of restorations and prostheses ●

    BEAUTIFIL Bulk
    (Indications)
    Direct posterior restorations using a light-curing resin paste to be used for masking the substructure color of dental restorations.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a correspondence from the FDA regarding the 510(k) clearance of the "BEAUTIFIL e Posterior / BEAUTIFIL Bulk" dental device. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.

    The document primarily focuses on the FDA's "substantial equivalence" determination to legally marketed predicate devices, meaning it allows the device to be marketed. It does not include the detailed technical study information you are asking for.

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