BEUDAMED
    Product Code: EKO FDA class 2 21 CFR 872.3600

    Denture Preformed (Partially Prefabricated Denture)

    Dental

    The Partially Prefabricated (Preformed) Denture is a dental prosthesis fabricated in advance to approximate standard dental arch forms, intended to be adjusted, relined, or trimmed chairside or in a laboratory to provide a more immediate prosthetic solution for edentulous patients. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is EKO, regulated under 21 CFR 872.3600 in the Dental (DE) specialty.

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    510(k)s
    4
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    4
    Years Active
    14

    Basic Information

    Product Code
    EKO
    Device Class
    FDA class 2
    Regulation Number
    872.3600
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K903672 DENE BRIDGE
    K892255 DENTAL ROOT ELEVATOR
    K780722 ADVANCED DENTURE SYSTEM
    K760768 FLEXIDENT DENTURE

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.