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510(k) Data Aggregation

    K Number
    K971733
    Device Name
    2 BOND 2
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    1997-10-02

    (146 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

    The 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges.

    2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental bonding system called "2 bond 2." It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. The letter is an administrative document indicating that the device has been cleared for market based on substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a technical document, a clinical study report, or a summary of safety and effectiveness for the "2 bond 2" device, which typically accompanies a 510(k) submission but is not included in this clearance letter.

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