BEUDAMED
    Product Code: MPI FDA class 3 21 CFR 872.3950

    Glenoid Fossa Prosthesis

    Dental

    The Glenoid Fossa Prosthesis is a dental implant used to replace the glenoid fossa component of the temporomandibular joint (TMJ) in patients requiring total joint reconstruction due to severe TMJ disease, trauma, or degenerative conditions. Classified as FDA Class 3 under 21 CFR 872.3950 in the Dental specialty, it requires Premarket Approval (PMA) due to its high-risk, implantable nature. The product code is MPI, and it carries an implant flag.

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    Basic Information

    Product Code
    MPI
    Device Class
    FDA class 3
    Regulation Number
    872.3950
    Medical Specialty
    Dental
    Review Panel
    DE
    Submission Type
    2

    Device Characteristics

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