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

    REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN

    K Number: K801235 · Decision Jun 20, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    54
    Applicant Total
    9
    Review Days
    24

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    Basic Information

    Device Name
    REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
    K Number
    K801235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3590
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Oki Shiks USA , Ltd.
    Date Received
    May 27, 1980
    Decision Date
    June 20, 1980
    Product Code
    ELM
    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
    ELM Denture, Plastic, Teeth

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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
    K801237 REIGNING CROWN-BRIDGE/POLYCARB. RESIN
    K801234 REIGNING DENTURE MADE OF POLYCARB. RESIN