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510(k) Data Aggregation

    K Number
    K051707
    Device Name
    ECLIPSE BONDING AGENT
    Manufacturer
    DENTSPLY INTL.
    Date Cleared
    2005-07-15

    (18 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K982007
    Why did this record match?
    Device Name :

    ECLIPSE BONDING AGENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    ECLIPSE® BONDING AGENT is indicated for use in enhancing the bond of acrylic teeth to acrylic removable denture bases.

    Device Description

    The ECLIPSE® BONDING AGENT is a blend of reactive dimers and oligomers in a solvent vehicle. These reactive entities, once initiated, undergo polymerization across the interface between the acrylic tooth and the denture base resin, forming a strong and lasting bond. This formulation has been shown to be particularly effective in initiating and maintaining the bond between acrylic denture teeth and both pour and light-curable denture base resins.

    The device is intended for use in the dental laboratory, by trained technicians, for the purpose of enhancing the bond between plastic denture teeth and cured denture base resins.

    AI/ML Overview

    The provided text is a 510(k) summary for the ECLIPSE® BONDING AGENT, a dental device. It does not contain any information regarding acceptance criteria or a study demonstrating the device meets such criteria.

    The document primarily focuses on:

    • Device Description: A blend of reactive dimers and oligomers in a solvent vehicle for bonding acrylic denture teeth to denture base resins.
    • Intended Use: Enhancing the bond of acrylic teeth to acrylic removable denture bases.
    • Technological Characteristics: States that components have been used in legally marketed devices and that modifications to the marketed device (Trubyte® Denture Bond Denture Bonding Agent, K982007) demonstrate the effectiveness of ECLIPSE® BONDING AGENT.
    • Regulatory Information: Classification, predicate device, and the FDA's decision of substantial equivalence.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text. The submission relies on the substantial equivalence to a predicate device (Trubyte® Denture Bond Denture Bonding Agent, K982007) and the prior safe use of its components, rather than presenting a de novo study with specific performance acceptance criteria.

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