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    FDA 510(k) FDA class 1 Substantially Equivalent 🇫🇷 France

    HERO 642

    K Number: K970649 · Decision May 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    160
    Registration Numbers
    160
    Same Product Code
    30
    Applicant Total
    2
    Review Days
    85

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    Basic Information

    Device Name
    HERO 642
    K Number
    K970649
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Mega
    Date Received
    February 20, 1997
    Decision Date
    May 16, 1997
    Product Code
    EKS
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EKS File, Pulp Canal, Endodontic

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