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510(k) Data Aggregation

    K Number
    K033267
    Device Name
    EPRICORD
    Manufacturer
    KURARAY MEDICAL INC.
    Date Cleared
    2003-12-22

    (74 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EPRICORD

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

    Epricord is indicated for the following applications:

      1. Restorations using facing crowns, facing bridges, or jacket crowns.
      1. Repairs of the polymer crown and bridge material or porcelain of facing crowns and jacket crowns.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a dental resin material named Epricord. It confirms that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information about:

    • Acceptance criteria for a study
    • Reported device performance values
    • Details of any specific study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details)

    The content is purely an FDA regulatory clearance notice, not a study report or clinical trial summary.

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