march 6, 2008bureau of radiological health cone beam computed tomography
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March 6, 2008 Bureau 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 DosimetryE
ffect
ive
dose
(S
v)
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).
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