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510(k) Data Aggregation

    K Number
    K180803
    Device Name
    BeautiBond Universal
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2018-09-26

    (182 days)

    Product Code
    KLE,EBF,EMA
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Direct restorations with light-cured composite resin
    • Repairs of fractured restorations with light-cured composite resin
    • Cementation of indirect restorations with light- or dual-cured resin cement
    • Core build-up with light- or dual-cured core materials
    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to an FDA 510(k) clearance for a dental bonding agent called "BeautiBond Universal". It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document states:

    • Trade/Device Name: BeautiBond Universal
    • Regulation Number: 21 CFR 872.3200
    • Regulation Name: Resin Tooth Bonding Agent
    • Regulatory Class: Class II

    The FDA's 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through the kind of study detailed in the request. For a Class II device like this bonding agent, substantial equivalence is typically established by comparing the device's technological characteristics and performance data to that of a predicate device. This usually involves bench testing (e.g., bond strength, cytotoxicity, biocompatibility) rather than studies with expert readers, AI, or ground truth as described in the prompt.

    Therefore, I cannot provide the requested information based on the given text. The text does not detail:

    • Acceptance criteria table or reported device performance against such criteria.
    • Sample sizes for test sets or data provenance.
    • Number/qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness study or effect sizes of human readers with/without AI.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Sample size for training set.
    • How ground truth for the training set was established.

    This is a regulatory clearance document for a physical medical device, not a software or AI-powered device, hence the absence of such information.

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