BEUDAMED
    Product Code: KON FDA class 3 21 CFR 872.3480

    Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

    Dental

    This Denture Adhesive formulated with modified cationic polyacrylamide polymer is a dental product applied to removable dentures to improve their retention on the oral mucosa. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to safety concerns associated with the polyacrylamide polymer formulation; the FDA issued a call for PMAs with a deadline of December 26, 1996, per 61 FR 50707 (September 26, 1996). The product code is KON and it is regulated under 21 CFR 872.3480 in the Dental specialty.

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    Basic Information

    Product Code
    KON
    Device Class
    FDA class 3
    Regulation Number
    872.3480
    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

    Definition

    Call for PMAs 12/26/96 per 61 FR 50707 on 9/26/96