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

    REIGNING CROWN-BRIDGE/POLYCARB. RESIN

    K Number: K801237 · Decision Jun 9, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    9
    Review Days
    13

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    Basic Information

    Device Name
    REIGNING CROWN-BRIDGE/POLYCARB. RESIN
    K Number
    K801237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Oki Shiks USA , Ltd.
    Date Received
    May 27, 1980
    Decision Date
    June 9, 1980
    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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    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
    K802489 REIGNING CROWN BRIDGE
    K801236 REIGNING EPOXY RESIN CEMENT
    K801235 REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
    K801234 REIGNING DENTURE MADE OF POLYCARB. RESIN