BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    STEADFAST DENTURE ADHESIVE POWDER

    K Number: K910216 · Decision Mar 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    71

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    Basic Information

    Device Name
    STEADFAST DENTURE ADHESIVE POWDER
    K Number
    K910216
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3400
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Stiefel Research Institute, Inc.
    Date Received
    January 17, 1991
    Decision Date
    March 29, 1991
    Product Code
    KOM
    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
    KOM Adhesive, Denture, Acacia And Karaya With Sodium Borate

    Other Clearances by Stiefel Research Institute, Inc.

    K Number Device Name
    K914591 L.C.S. 2000 SYSTEM
    K895818 STEADFAST DENTURE ADHESIVE CREAM
    K895817 HERMAL WOUND CARE KIT
    K896724 CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
    K893996 CUSIS ULTRASOUND SKIN IMAGING SYSTEM