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510(k) Data Aggregation

    K Number
    K120159
    Device Name
    BEAUTICEM SA
    Manufacturer
    SHOFU DENTAL CORPORATION
    Date Cleared
    2012-06-18

    (151 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BeautiCem SA is intended for cementation of dental restorations, dental restorative materials and prostheses to intraoral hard tissues, specifically intended for cementation of restorations (inlays, onlays, crowns, bridges, etc.) made of metal, ceramics (porcelain, alumina, or zirconia) or resin material to natural teeth. BeautiCem SA is also intended for cementation of indirectly prepared metal-core or resin-core to natural teeth.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Shofu Dental Corporation regarding a dental cement product called BEAUTICEM SA. It confirms the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the FDA's clearance letter. The letter primarily states the regulatory decision and relevant compliance information.

    Therefore, I cannot provide the requested information based on the input text.

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