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510(k) Data Aggregation

    K Number
    K110252
    Manufacturer
    Date Cleared
    2011-05-13

    (105 days)

    Product Code
    Regulation Number
    872.3200
    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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    K Number
    K110235
    Device Name
    BEAUTIBOND MULTI
    Manufacturer
    Date Cleared
    2011-05-13

    (107 days)

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

    BEAUTIBOND MULTI

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

    BeautiBond Multi is intended for bonding composite resin to cavity or lesion including dentin. It is also intended for bonding composite resin to ceramics, composite resin, and metals to repair fractured restorations or prostheses.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided document is an FDA 510(k) clearance letter for a dental bonding agent (BeautiBond Multi). It confirms that the device is substantially equivalent to legally marketed predicate devices.

    This type of document does not contain the detailed study information, acceptance criteria, or performance data that your request asks for. This information (like sample sizes, expert qualifications, adjudication methods, ground truth, etc.) would typically be found in the actual 510(k) submission summary or a scientific publication related to the device.

    Therefore, I cannot provide the requested table and study details based on the given text.

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