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

    HELIO LINK (RESIN CEMENT)

    K Number: K901910 · Decision Jun 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    205
    Registration Numbers
    205
    Same Product Code
    913
    Applicant Total
    131
    Review Days
    61

    Basic Information

    Device Name
    HELIO LINK (RESIN CEMENT)
    K Number
    K901910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    IVOCLAR NORTH AMERICA, INC.
    Date Received
    April 26, 1990
    Decision Date
    June 26, 1990
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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