BEUDAMED
    Product Code: KOM FDA class 1 21 CFR 872.3400

    Adhesive, Denture, Acacia And Karaya With Sodium Borate

    Dental

    This Denture Adhesive formulated with acacia and karaya with sodium borate is a dental device applied to the inner surface of removable dentures to enhance their retention and fit by creating an adhesive bond between the denture and the gum tissue. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket submission required. The product code is KOM and the applicable regulation is 21 CFR 872.3400 in the Dental specialty.

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    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KOM
    Device Class
    FDA class 1
    Regulation Number
    872.3400
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K910216 STEADFAST DENTURE ADHESIVE POWDER

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.