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

    WIRON 99 DENTAL CASTING ALLOY

    K Number: K903538 · Decision Mar 15, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    152
    Applicant Total
    31
    Review Days
    220

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    Basic Information

    Device Name
    WIRON 99 DENTAL CASTING ALLOY
    K Number
    K903538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3710
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Leach and Dillon Co., Inc.
    Date Received
    August 7, 1990
    Decision Date
    March 15, 1991
    Product Code
    EJH
    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
    EJH Alloy, Metal, Base

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