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

    AGALLOY, DISALLOY, EPSILON AND LAMBDA

    K Number: K942430 · Decision Jul 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    73
    Applicant Total
    3
    Review Days
    55

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    Basic Information

    Device Name
    AGALLOY, DISALLOY, EPSILON AND LAMBDA
    K Number
    K942430
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fen Dental Mfg., Inc.
    Date Received
    May 20, 1994
    Decision Date
    July 14, 1994
    Product Code
    EJJ
    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
    EJJ Alloy, Amalgam

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