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510(k) Data Aggregation

    K Number
    K012730
    Device Name
    CLEARFIL PORCELAIN BOND ACTIVATOR
    Manufacturer
    KURARAY MEDICAL INC.
    Date Cleared
    2001-09-13

    (30 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K871636,K900690,K925404
    Why did this record match?
    Reference Devices :

    K871636, K900690

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

    CLEAFIL PORCELAIN BOND ACTIVATOR is indicated for the following applications:

    1. Repair of porcelain or porcelain fused-to-metal crowns and bridges
    2. Restoration of gingival porcelain areas where bonding to porcelain is necessary
    3. Increased retention of porcelain inlays, onlays, crowns and veneers
    4. Increased retention of composite inlays and onlays
    Device Description

    This product is contained in CLEARFIL PORCELAIN BOND (K871636) and CLEARFIL VENEER BOND (K900690) which has been submitted to FDA as 510k notifications and permitted to be marketed already.

    AI/ML Overview

    The provided text (K012730) describes a 510(k) premarket notification for a medical device called "CLEARFIL PORCELAIN BOND ACTIVATOR." However, this document does not contain information about acceptance criteria, device performance metrics, or any studies using AI or human readers.

    The 510(k) submission is specifically to:

    • Alter the name and address of the manufacturer from Kuraray Co., Ltd. to Kuraray Medical Inc.
    • Confirm that the device is substantially equivalent to a previously cleared predicate device (CLEARFIL PORCELAIN BOND ACTIVATOR by Kuraray Co., Ltd., K925404).

    The document explicitly states that "The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes" and "This device is essentially the same as CLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Co., Ltd. (K925404). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL PORCELAIN BOND ACTIVATOR."

    Because of this, there are no new studies or performance data presented in this specific 510(k) summary. All performance and safety data would have been part of the original K925404 submission for the predicate device.

    Therefore, I cannot provide the requested information based on the input text. The questions about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not addressed in this document.

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