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

    ARGI-SATIN OR OPTI0-STAR

    K Number: K965216 · Decision Feb 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    217
    Review Days
    59

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    Basic Information

    Device Name
    ARGI-SATIN OR OPTI0-STAR
    K Number
    K965216
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Argen Precious Metals, Inc.
    Date Received
    December 30, 1996
    Decision Date
    February 27, 1997
    Product Code
    ELL
    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
    ELL Teeth, Porcelain

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