BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇽 Mexico

    MERCURY DENTAL

    K Number: K973548 · Decision Mar 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    186

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    Basic Information

    Device Name
    MERCURY DENTAL
    K Number
    K973548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aleaciones Dentales Zeyco, S.A. DE C.V.
    Date Received
    September 18, 1997
    Decision Date
    March 23, 1998
    Product Code
    ELY
    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
    ELY Mercury

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