BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE

    K Number: K853089 · Decision Apr 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    147
    Registration Numbers
    147
    Same Product Code
    399
    Applicant Total
    6
    Review Days
    272

    Basic Information

    Device Name
    SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE
    K Number
    K853089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    PSP DENTAL CO., LTD.
    Date Received
    July 23, 1985
    Decision Date
    April 21, 1986
    Product Code
    ELW
    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
    ELW Material, Impression

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