BEUDAMED
    Product Code: ELS FDA class 2 21 CFR 872.3890

    Splint, Endodontic Stabilizing

    Dental

    The Endodontic Stabilizing Splint is a dental device used to splint and immobilize mobile or traumatized teeth, distributing occlusal forces across multiple teeth and allowing the periodontium and supporting structures to heal following trauma, periodontal disease, or endodontic treatment. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELS, regulated under 21 CFR 872.3890 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    6
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    6
    Years Active
    17

    Basic Information

    Product Code
    ELS
    Device Class
    FDA class 2
    Regulation Number
    872.3890
    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 6 510(k) clearances via K numbers.

    K Number Device Name
    K972985 SPLINT IT
    K961704 MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM
    K922673 FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING
    K834363 ENDIX RADICULAR BIOCERAMIC PIN
    K811209 JACOB WIRZ TRANSFIXATION PIN
    K801525 ZEST ENDODONTIC STABILIZER

    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.