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

    STEADFAST DENTURE ADHESIVE CREAM

    K Number: K895818 · Decision Apr 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    7
    Applicant Total
    6
    Review Days
    186

    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
    STEADFAST DENTURE ADHESIVE CREAM
    K Number
    K895818
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3490
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Stiefel Research Institute, Inc.
    Date Received
    September 29, 1989
    Decision Date
    April 3, 1990
    Product Code
    KOT
    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
    KOT Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

    Similar 510(k) Clearances

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

    SUPER POLI-GRIP DENTURE ADHESIVE CREAM

    FDA 510(k)
    FDA Class 1 ·Dental

    MPI DENTURE ADHESIVE FILM SEALS

    FDA 510(k)
    FDA Class 1 ·Dental

    SUPER STRENGTH DENTURE ADHESIVE CREAM

    FDA 510(k)
    FDA Class 1 ·Dental

    PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER

    FDA 510(k)
    FDA Class 1 ·Dental

    RIGIDENT CREAM

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Stiefel Research Institute, Inc.

    K Number Device Name
    K914591 L.C.S. 2000 SYSTEM
    K910216 STEADFAST DENTURE ADHESIVE POWDER
    K895817 HERMAL WOUND CARE KIT
    K896724 CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
    K893996 CUSIS ULTRASOUND SKIN IMAGING SYSTEM