BEUDAMED
    Product Code: ELE FDA class 2 21 CFR 872.3645

    Implant, Subperiosteal

    Dental

    The Subperiosteal Implant is a custom-fabricated metal framework designed to rest on top of the jawbone beneath the periosteum, with posts protruding through the gingiva to support a dental prosthesis in patients who cannot accommodate endosseous implants due to inadequate bone volume. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELE, regulated under 21 CFR 872.3645 in the Dental (DE) specialty. This device is an implant.

    View on FDA
    510(k)s
    4
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    4
    Years Active
    42

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    Basic Information

    Product Code
    ELE
    Device Class
    FDA class 2
    Regulation Number
    872.3645
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    1

    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
    K210228 KLS Martin IPS Preprosthetic
    K862926 SURGICAL VITEX
    K843557 K-APATITE 20-40 MESH K-APATITE 40-60
    K801208 HOLLOW BASKET TITANIUM DENTAL IMPLANT

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.