BEUDAMED
    Product Code: KOL FDA class 1 21 CFR 872.3410

    Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer

    Dental

    This Denture Adhesive formulated with carboxymethylcellulose sodium (32%) and ethylene-oxide homopolymer is a dental device applied to the fitting surface of removable dentures to improve retention and stability by creating a mucoadhesive bond between the denture base and oral mucosa. It is classified as FDA Class 1, indicating low risk subject to general controls only with no premarket clearance required. The product code is KOL and it falls under 21 CFR 872.3410 in the Dental specialty.

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    510(k)s
    2
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    2
    Years Active
    9

    Basic Information

    Product Code
    KOL
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K884999 HOLD-FAST DENTURE ADHESIVE
    K791576 FORGET - DENTURE BONDING LIQUID

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.