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510(k) Data Aggregation

    K Number
    K980539
    Device Name
    SOLOBOND M
    Manufacturer
    VOCO GMBH
    Date Cleared
    1998-03-23

    (39 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K994056
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Solobond M is intended for use as an adhesive bond between hard dental tissue (dentin / enamel) and light-curing restorative materials.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental bonding agent called "Solobond M." It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    The letter is a regulatory approval, not a scientific study report. It indicates that the manufacturer submitted data to demonstrate substantial equivalence, but the details of those studies are not present in this document.

    Therefore, I cannot fulfill your request for the specific information you asked for based on the provided text.

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