BEUDAMED
    Product Code: LZD FDA class 3 21 CFR 872.3940

    Joint, Temporomandibular, Implant

    Dental

    The Temporomandibular Joint Implant (product code LZD) is a prosthetic dental device surgically implanted to reconstruct the temporomandibular joint (TMJ) in patients with severe joint disease, degeneration, or trauma where other treatments have failed. Regulated under 21 CFR 872.3940 and classified as a Class 3 device requiring Premarket Approval (PMA), it was subject to a call for PMAs per 63 FR 71746 (December 1998). The device is flagged as an implant and falls under the Dental specialty. It is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LZD
    Device Class
    FDA class 3
    Regulation Number
    872.3940
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.