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

    SUPER POLI-GRIP DENTURE ADHESIVE CREAM

    K Number: K945462 · Decision Dec 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    7
    Applicant Total
    10
    Review Days
    43

    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
    SUPER POLI-GRIP DENTURE ADHESIVE CREAM
    K Number
    K945462
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3490
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Block Drug Company, Inc.
    Date Received
    November 7, 1994
    Decision Date
    December 20, 1994
    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.

    MPI DENTURE ADHESIVE FILM SEALS

    FDA 510(k)
    FDA Class 1 ·Dental

    SUPER STRENGTH DENTURE ADHESIVE CREAM

    FDA 510(k)
    FDA Class 1 ·Dental

    STEADFAST 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 Block Drug Company, Inc.

    K Number Device Name
    K935925 VISION PROPHY PASTE WITH FLUORIDE
    K933893 VISION PROPHY PASTE WITHOUT FLUORIDE
    K884533 SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM
    K881974 PROFICIENT(TM) PROPHYLAXIS ANGLE
    K872225 SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER
    K862876 NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM
    K800831 PY-CO-PROX TM DENTAL BRUSH
    K791064 DUO TWO LAYER DENTURE CLEANSER
    K780849 DENTROL LIQUID DENTURE ADHESIVE