BEUDAMED
    Product Code: ELO FDA class 1 21 CFR 872.3350

    Cusp, Gold And Stainless Steel

    Dental

    The Gold and Stainless Steel Cusp is a preformed metal dental component made of gold or stainless steel used to restore or reinforce a damaged or missing tooth cusp on a prosthetic tooth or natural tooth restoration, providing durable occlusal function. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is ELO, regulated under 21 CFR 872.3350 in the Dental (DE) specialty.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    ELO
    Device Class
    FDA class 1
    Regulation Number
    872.3350
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
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    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.