BEUDAMED
    Product Code: KOS FDA class 3 21 CFR 872.3420

    Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer

    Dental

    This device is a denture adhesive containing carboxymethylcellulose sodium combined with cationic polyacrylamide polymer, intended to retain removable dental prostheses. It is classified as FDA Class 3, the highest risk level, requiring Premarket Approval (PMA) due to the potential toxicity concerns associated with cationic polyacrylamide polymer ingredients. The product code is KOS, regulated under 21 CFR 872.3420 within the Dental specialty. No special flags such as implant or life-sustaining designations apply.

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    510(k)s
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    FEI Numbers
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    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    KOS
    Device Class
    FDA class 3
    Regulation Number
    872.3420
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    Summary Malfunction Reporting