BEUDAMED
    Product Code: EHR FDA class 2 21 CFR 872.3540

    Pad, Denture, Over The Counter

    Dental

    The Over-The-Counter Denture Pad is a consumer-use cushioning material sold without a prescription, applied between a removable denture base and the oral mucosa to improve denture fit, comfort, and retention for edentulous patients. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance and compliance with special controls. The product code is EHR, regulated under 21 CFR 872.3540 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    EHR
    Device Class
    FDA class 2
    Regulation Number
    872.3540
    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 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.