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

    BIOGOLD PLUS DENTAL ALLOY

    K Number: K980660 · Decision Apr 27, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    626
    Applicant Total
    7
    Review Days
    66

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    Basic Information

    Device Name
    BIOGOLD PLUS DENTAL ALLOY
    K Number
    K980660
    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
    February 20, 1998
    Decision Date
    April 27, 1998
    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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