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510(k) Data Aggregation

    K Number
    K051006
    Device Name
    IBOND NEXT GENERATION
    Manufacturer
    HERAEUS KULZER GMBH
    Date Cleared
    2005-06-07

    (48 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IBOND NEXT GENERATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Bonding of direct composite restorations (including Polyglas® and Compomer)
    • Bonding of direct composite restoration with a light-curing luting cement:
    • Bonding of indirect restoration in combination with a light-curing luting cement: Porcelain, Polyglas®, and composite restorations (inlays, onlays, veneers, crowns).
    • Sealing hypersensitive areas of teeth.
    Device Description

    Not Found

    AI/ML Overview

    The input document does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding clearance for their "iBond™ Next Generation" resin tooth bonding agent. It outlines the regulatory classification, general controls, and indications for use of the device.

    Therefore, I cannot extract the requested information from the provided text.

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