BEUDAMED
    Product Code: EHA FDA class 1 21 CFR 872.1820

    Aligner, Beam, X-Ray

    Dental

    The X-Ray Beam Aligner is a dental device that attaches to the X-ray tube head and patient film holder to align the central X-ray beam perpendicular to the film, reducing geometric distortion and improving diagnostic image quality. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHA, regulated under 21 CFR 872.1820 in the Dental (DE) specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    EHA
    Device Class
    FDA class 1
    Regulation Number
    872.1820
    Medical Specialty
    Dental
    Review Panel
    DE
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K891186 REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT

    FEI Numbers

    This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.