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

    REIGNING CROWN BRIDGE

    K Number: K802489 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    180
    Registration Numbers
    180
    Same Product Code
    188
    Applicant Total
    9
    Review Days
    33

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    Basic Information

    Device Name
    REIGNING CROWN BRIDGE
    K Number
    K802489
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3770
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Oki Shiks USA , Ltd.
    Date Received
    October 10, 1980
    Decision Date
    November 12, 1980
    Product Code
    EBG
    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
    EBG Crown And Bridge, Temporary, Resin

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    Other Clearances by Oki Shiks USA , Ltd.

    K Number Device Name
    K821217 REIGNING DENTURE
    K802490 REIGNING DENTURE
    K802491 REIGNING REPAIR EPOXY RESIN
    K802492 REIGNING ARTIFICIAL TEETH
    K801236 REIGNING EPOXY RESIN CEMENT
    K801235 REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
    K801237 REIGNING CROWN-BRIDGE/POLYCARB. RESIN
    K801234 REIGNING DENTURE MADE OF POLYCARB. RESIN