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510(k) Data Aggregation

    K Number
    K971121
    Device Name
    ENCORE BOND
    Manufacturer
    CENTRIX, INC.
    Date Cleared
    1997-06-27

    (92 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

    ENCORE BOND is a self-cure bonding agent for dentin and enamel and the considering is and applied in a thin coating to ENCORE BOND is a self-cure bonding agains a thin coating to tooth surfaces. It is mixed and apprica in a case of the composite resins to tooth structure.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to Centrix Incorporated regarding their device, Encore Bond. It states that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976, and therefore can be marketed.

    However, this document DOES NOT contain information about acceptance criteria, device performance results, study design details (sample sizes, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, or standalone performance), or training set information.

    The document is purely a regulatory approval letter. To answer the questions posed, I would need access to the actual 510(k) submission summary or detailed study reports for Encore Bond, which are not included in the provided text.

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