BEUDAMED
    Product Code: KXW FDA class 1 21 CFR 872.3410

    Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer

    Dental

    The Carboxymethylcellulose Sodium and Ethylene-Oxide Homopolymer Denture Adhesive is a dental device formulated to improve the retention and stability of removable dentures by adhering the denture base to the oral mucosa, facilitating daily comfort and function for denture wearers. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KXW, regulated under 21 CFR 872.3410, in the Dental medical specialty. No special flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    KXW
    Device Class
    FDA class 1
    Regulation Number
    872.3410
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.