March 6, 2008Bureau of Radiological Health Cone Beam Computed Tomography

NewTom 3G by AFP MercuRay by Hitachi 3D Accuitomo by J. Morita Cone-beam Units Galileos by Sirona I-CAT by ISI Iluma by IMTEC

Source; Stuart White- UCLA School of Dentistry Comparative Dosimetry Effective dose ( Sv)

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 Uneven magnification distortion Dolphin Imaging

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: (g).