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510(k) Data Aggregation

    K Number
    K980298
    Device Name
    FLOWABLE HYBRID
    Manufacturer
    COSMEDENT, INC.
    Date Cleared
    1998-03-09

    (41 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Flowable Hybrid is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental device called "Flowable Hybrid". This document establishes that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use.

    However, this document does NOT contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth establishment for AI/ML-based device development.

    The letter is a regulatory approval for a physical dental product (Flowable Hybrid) based on its equivalence to existing products, not an AI/ML device that would require detailed performance metrics from a study as typically outlined in your request.

    Therefore, I cannot provide the requested information based on the content of this document.

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