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

    AMALGAPHASE

    K Number: K921538 · Decision Aug 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    132

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    Basic Information

    Device Name
    AMALGAPHASE
    K Number
    K921538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Saskan Amalgam Alloys, Inc.
    Date Received
    March 31, 1992
    Decision Date
    August 10, 1992
    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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