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

    EL DORADO 40

    K Number: K964941 · Decision Jan 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    626
    Applicant Total
    31
    Review Days
    34

    Basic Information

    Device Name
    EL DORADO 40
    K Number
    K964941
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    GATEWAY ALLOYS, INC.
    Date Received
    December 10, 1996
    Decision Date
    January 13, 1997
    Product Code
    EJT
    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
    EJT Alloy, Gold-Based Noble Metal

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    Other Clearances by GATEWAY ALLOYS, INC.

    K Number Device Name
    K011661 CONCORD 88
    K011659 GPW-SF
    K011626 CONCORD 72
    K011628 CONCORD 82
    K964940 TAOS 28
    K964948 AURORA 52 (PM-01)
    K964950 LA PLATA 28 (PM-28)
    K964949 AURORA 53
    K964837 PACIFIC 56 (CB-40)
    K964789 LA PLATA 39
    Search all 31 clearances from GATEWAY ALLOYS, INC. →