BEUDAMED
    Product Code: KOR FDA class 3 21 CFR 872.3400

    Adhesive, Denture, Karaya With Sodium Borate

    Dental

    This device is a denture adhesive formulated with karaya and sodium borate, used to help hold removable dentures in place. Despite being a denture adhesive, it is classified as FDA Class 3, the highest risk category, which requires a Premarket Approval (PMA) application before it can be marketed. The product code is KOR, regulated under 21 CFR 872.3400 within the Dental specialty. The presence of sodium borate, a potentially toxic compound, is the basis for the elevated risk classification.

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

    Product Code
    KOR
    Device Class
    FDA class 3
    Regulation Number
    872.3400
    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