BEUDAMED
    Product Code: MDL FDA class 2 21 CFR 872.4760

    Implant, Transmandibular

    Dental

    The transmandibular implant is a dental implant surgically placed through the inferior border of the mandible to provide stable anchorage for mandibular denture prostheses in patients with severely resorbed mandibles who cannot use conventional dentures. It is classified as FDA Class II under 21 CFR 872.4760 within the Dental specialty, requiring 510(k) premarket clearance. The product code is MDL and it carries an implant flag reflecting its permanent surgical placement. Full GMP quality system requirements apply.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    5

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    Basic Information

    Product Code
    MDL
    Device Class
    FDA class 2
    Regulation Number
    872.4760
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K900433 SMOOTH STAPLE IMPLANT
    K852894 ORMCO TRANSMANDIBULAR IMPLANT