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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