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510(k) Data Aggregation

    K Number
    K110252
    Device Name
    BEAUTIBOND MULTI PR PLUS
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2011-05-13

    (105 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BEAUTIBOND MULTI PR PLUS

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

    BeautiBond Multi PR Plus is dental adhesive to ceramic, consisting primarily of surface treatment material (silane coupling agent). This product is intended for bonding composite resin to ceramics other than alumina and zirconia or composite resin to repair fractured restorations or prostheses.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental bonding agent, BeautiBond Multi PR Plus. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as it is a regulatory approval document and not a scientific study report.

    Therefore, I cannot extract the requested information from this document.

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