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510(k) Data Aggregation

    K Number
    K022612
    Device Name
    IBOND GLUMA INSIDE
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2002-10-28

    (83 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K041960
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bonding composite, comporner and Polyglas® resins to the tooth structure as well for indirect restorations (e.g. Anglass®, procelain) and sealing of prepared teeth prior to amalgam placement.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the limited information provided in the document, I cannot fulfill your request. The document is an FDA 510(k) clearance letter for a dental bonding agent (iBond™ Gluma® inside). It confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance requirements.

    However, the document does not contain any information about acceptance criteria, device performance data, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment as these details are typically found in the 510(k) submission itself, not the clearance letter.

    Therefore, I cannot generate the table or answer the specific questions about the study and performance metrics.

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