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510(k) Data Aggregation

    K Number
    K020050
    Device Name
    ENAMEL BONDING SYSTEM
    Manufacturer
    RITE-DENT MANUFACTURING CORP.
    Date Cleared
    2002-02-14

    (38 days)

    Product Code
    KLE
    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

    Rite-Dent Bonding System creates a bond between and all resin restorative materials. It consists of an Aola Lionany of the surface area for mechanical bonding. The The Librant clonod the onamer is interlock the etched area. After placement of Oatalyst and Dubo intinued and the monded enamel, a chemical bond will form between the composite and the tooth structure.

    Device Description

    Enamel Bonding System

    AI/ML Overview

    The provided text is a letter from the FDA regarding the 510(k) premarket notification for the "Enamel Bonding System" manufactured by Rite-Dent Manufacturing Corporation. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, this document does not contain information about acceptance criteria, device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

    The letter is a regulatory approval document and focuses on the substantial equivalence determination for market entry, not on the technical performance data that would typically be reported in a clinical or performance study.

    Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided text.

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