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

    REIGNING EPOXY RESIN CEMENT

    K Number: K801236 · Decision Jul 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    9
    Review Days
    42

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    REIGNING EPOXY RESIN CEMENT
    K Number
    K801236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Oki Shiks USA , Ltd.
    Date Received
    May 27, 1980
    Decision Date
    July 8, 1980
    Product Code
    EMA
    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
    EMA Cement, Dental

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EMA), ordered by most recent decision date.

    G-CEM UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    REGEN Bioactive Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    Bifix Veneer LC, Bifix Veneer Try-In

    FDA 510(k)
    FDA Class 2 ·Dental

    iCEM Universal Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    TopCEM Vigor SA Self-Adhesive Resin Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    GlasIonomer FX-LC

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    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
    K801235 REIGNING ARTIFICIAL TEETH/POLYCARB.RESIN
    K801237 REIGNING CROWN-BRIDGE/POLYCARB. RESIN
    K801234 REIGNING DENTURE MADE OF POLYCARB. RESIN