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  • 5 - Cone Beam Computed Tomography

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    Rajan Karmakar
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    Cone beam computed tomography (CBCT) is a 3D imaging technique increasingly used in dentistry for applications like treatment planning, dental implants, and evaluation of wisdom teeth and temporomandibular joints. The document discusses several CBCT unit models, their effective radiation doses, and regulatory issues around how they should be classified and operated given they are considered a type of computed tomography by the FDA. It suggests informing registrants that CBCT units fall under CT regulations and only certain licensed professionals can operate them, while giving time to implement new quality assurance programs.

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    5- Cone Beam Computed Tomography

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    Cone beam computed tomography (CBCT) is a 3D imaging technique increasingly used in dentistry for applications like treatment planning, dental implants, and evaluation of wisdom teeth and temporomandibular joints. The document discusses several CBCT unit models, their effective radiation doses, and regulatory issues around how they should be classified and operated given they are considered a type of computed tomography by the FDA. It suggests informing registrants that CBCT units fall under CT regulations and only certain licensed professionals can operate them, while giving time to implement new quality assurance programs.

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    31 views7 pages

    5 - Cone Beam Computed Tomography

    Uploaded by

    Rajan Karmakar
    Cone beam computed tomography (CBCT) is a 3D imaging technique increasingly used in dentistry for applications like treatment planning, dental implants, and evaluation of wisdom teeth and temporomandibular joints. The document discusses several CBCT unit models, their effective radiation doses, and regulatory issues around how they should be classified and operated given they are considered a type of computed tomography by the FDA. It suggests informing registrants that CBCT units fall under CT regulations and only certain licensed professionals can operate them, while giving time to implement new quality assurance programs.

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    Download as PPT, PDF, TXT or read online from Scribd
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    of 7

    Cone Beam Computed Tomography

    March 6, 2008

    Bureau of Radiological Health

    Cone-beam Units

    NewTom 3G by AFP

    Galileos by Sirona

    MercuRay by Hitachi

    I-CAT by ISI

    3D Accuitomo by J. Morita

    Iluma by IMTEC

    Comparative Dosimetry
    Effective dose (mSv)

    Source; Stuart White- UCLA School of Dentistry

    Dental Applications
    Broad acceptance in dentistry last five years
    Orthodontic treatment planning Dental implants

    Temporomandibular joints for osseous


    degenerative changes Evaluation of wisdom teeth vs. mandibular nerve Disease
    Source; Stuart White- UCLA School of Dentistry

    Cephalometric Analysis

    Source; Stuart White- UCLA School of Dentistry

    Bureau Issues
    How to regulate these sources?
    Appears that FDA has classified them as CT

    If CT, subject to QA requirements If CT, limited licensed technologists prohibited from operating unit Your thoughts?

    Source; Stuart White- UCLA School of Dentistry

    Suggested Regulatory Approach


    Advise all CBCT registrants that FDA classifies as CT (Once we officially confirm) Advise registrants that only the Dentist, Physician, Dental Hygienist(?) or Diagnostic Technologist can operate CBCT Provide registrants 90 days to develop and 180 days to implement alternative QA program as permitted by N.J.A.C. 7:28-22.3(g).
    Source; Stuart White- UCLA School of Dentistry

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