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

    ZONAREX FINAL IMPRESSION COMPOUND

    K Number: K896786 · Decision Apr 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    2
    Review Days
    136

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    Basic Information

    Device Name
    ZONAREX FINAL IMPRESSION COMPOUND
    K Number
    K896786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Craft Dental Laboratory, Inc.
    Date Received
    December 4, 1989
    Decision Date
    April 19, 1990
    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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    Other Clearances by Craft Dental Laboratory, Inc.

    K Number Device Name
    K896785 ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/