BEUDAMED
    Product Code: ELN FDA class 1 21 CFR 872.3580

    Teeth, Preformed Gold Denture

    Dental

    Preformed Gold Denture Teeth are prefabricated artificial teeth made of gold alloy for use in complete or partial dentures, providing durability and biocompatibility in patients requiring metallic occlusal surfaces for optimal wear resistance and function. They are classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is ELN, regulated under 21 CFR 872.3580 in the Dental (DE) specialty.

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    510(k)s
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    ELN
    Device Class
    FDA class 1
    Regulation Number
    872.3580
    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
    K770872 IMPRESSION MATERIAL, ALGINATE

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.