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 Dosimetry
E
f
f
e
c
t
i
v
e

d
o
s
e

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m
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).