BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KROMATICA COLOR CHANGING ALGINATE

    K Number: K974894 · Decision Feb 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    6
    Review Days
    43

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    Basic Information

    Device Name
    KROMATICA COLOR CHANGING ALGINATE
    K Number
    K974894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Matech, Inc.
    Date Received
    December 31, 1997
    Decision Date
    February 12, 1998
    Product Code
    ELW
    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
    ELW Material, Impression

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