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

    ORION WX DENTAL ALLOY

    K Number: K981002 · Decision May 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    193
    Applicant Total
    7
    Review Days
    61

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    Basic Information

    Device Name
    ORION WX DENTAL ALLOY
    K Number
    K981002
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    European Dental Imports, Inc.
    Date Received
    March 18, 1998
    Decision Date
    May 18, 1998
    Product Code
    EJS
    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
    EJS Alloy, Other Noble Metal

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