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

    CUSHIONS, DENTURE ADHESIVE, ALL-DAY

    K Number: K770413 · Decision Jun 24, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    2
    Applicant Total
    6
    Review Days
    112

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    Basic Information

    Device Name
    CUSHIONS, DENTURE ADHESIVE, ALL-DAY
    K Number
    K770413
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3540
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Combe, Inc.
    Date Received
    March 4, 1977
    Decision Date
    June 24, 1977
    Product Code
    EHS
    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
    EHS Cushion, Denture, Over The Counter

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    K770175 SEA-BOND ADHEVISE DENTURE CUSHIONS