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510(k) Data Aggregation

    K Number
    K043177
    Device Name
    CLEAFIL DC CORE AUTOMIX
    Manufacturer
    KURARAY MEDICAL INC.
    Date Cleared
    2004-12-17

    (31 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K062410,K111982,K131432
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CLEARFIL DC CORE AUTOMIX is indicated for the following application 1) Core build up of vital or non-vital tooth

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called "CLEARFIL™ DC Core Automix". This document primarily focuses on regulatory approval and does not contain the specific information requested regarding acceptance criteria for a study, device performance data, sample sizes, expert qualifications, or details about a comparative effectiveness study.

    Therefore, I cannot extract the information to answer your questions based on the provided text.

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