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510(k) Data Aggregation

    K Number
    K213965
    Device Name
    BeautiBond Xtreme
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2022-03-18

    (88 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 Xtreme

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Direct restorations with light-cured composite resin
    • Repair of fractured restorations with light-cured composite resin
    • Post cementation and core build-up
    • Cementation of indirect restorations with light-cured/dual-cured resin cement
    • Treatment of hypersensitive teeth or exposed root surface
    • Sealing of tooth preparation (cavity or abutment) for indirect restorations
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study proving the device meets those criteria.

    The document is an FDA 510(k) clearance letter for a dental bonding agent named "BeautiBond Xtreme." It primarily

    • Confirms the FDA's review and determination of substantial equivalence for the device.
    • Outlines the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device.
    • Lists the indications for use of the device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.

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