BEUDAMED
    Product Code: NEI FDA class 2 21 CFR 872.4770

    Prosthesis, Condyle, Mandibular, Temporary

    Dental

    The Prosthesis, Condyle, Mandibular, Temporary (product code NEI) is a temporary dental/maxillofacial implant used to replace the mandibular condyle on a short-term basis, typically during staged reconstructive surgery of the temporomandibular joint. It is an FDA Class 2 device within the Dental specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. As a surgically placed prosthesis, it carries an implant designation and is not flagged as life-sustaining.

    View on FDA
    510(k)s
    7
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    5
    Years Active
    14

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    Basic Information

    Product Code
    NEI
    Device Class
    FDA class 2
    Regulation Number
    872.4770
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K133285 STRYKER TEMPORARY CONDYLAR PROSTHESIS
    K081747 MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
    K063181 SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
    K031701 OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
    K002790 ADD-ON CONDYLE
    K990667 KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
    K990637 SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.