BEUDAMED
    Product Code: EAH FDA class 1 21 CFR 872.1850

    Cone, Radiographic, Lead-Lined

    Dental

    The Lead-Lined Radiographic Cone is a dental device attached to an intraoral X-ray tube head to collimate the X-ray beam, direct it toward the dental film or sensor, and limit patient radiation exposure. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EAH and the applicable regulation is 21 CFR 872.1850, under the Dental medical specialty.

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    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    2
    Years Active
    6

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    Basic Information

    Product Code
    EAH
    Device Class
    FDA class 1
    Regulation Number
    872.1850
    Medical Specialty
    Dental
    Review Panel
    RA
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K840275 CEHPALOMETRIC HEAD POSITIONER
    K771748 INTRA ORAL X-RAY CONES