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

    OTC DENTURE CLEANSER

    K Number: K942203 · Decision Aug 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    127
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    97

    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
    OTC DENTURE CLEANSER
    K Number
    K942203
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3520
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Combe, Inc.
    Date Received
    May 5, 1994
    Decision Date
    August 10, 1994
    Product Code
    EFT
    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
    EFT Cleanser, Denture, Over The Counter

    Similar 510(k) Clearances

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

    CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER

    FDA 510(k)
    FDA Class 1 ·Dental

    MEDICAL INTERPOROUS

    FDA 510(k)
    FDA Class 1 ·Dental

    TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND

    FDA 510(k)
    FDA Class 1 ·Dental

    PROFAST(R)-DENTURE CLEANSER

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTURE PRODUCT X

    FDA 510(k)
    FDA Class 1 ·Dental

    CFR MONOGRAPH

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

    Other Clearances by Combe, Inc.

    K Number Device Name
    K925259 CFR MONOGRAPH
    K863375 SEA-BOND
    K780719 FUNGUS FIGHTER INSOLES
    K770413 CUSHIONS, DENTURE ADHESIVE, ALL-DAY
    K770175 SEA-BOND ADHEVISE DENTURE CUSHIONS