BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SEA-BOND ADHEVISE DENTURE CUSHIONS

    K Number: K770175 · Decision Feb 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    6
    Review Days
    9

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    Basic Information

    Device Name
    SEA-BOND ADHEVISE DENTURE CUSHIONS
    K Number
    K770175
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Combe, Inc.
    Date Received
    January 26, 1977
    Decision Date
    February 4, 1977
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Combe, Inc.

    K Number Device Name
    K942203 OTC DENTURE CLEANSER
    K925259 CFR MONOGRAPH
    K863375 SEA-BOND
    K780719 FUNGUS FIGHTER INSOLES
    K770413 CUSHIONS, DENTURE ADHESIVE, ALL-DAY