Cone Beam Computed

Tomography

March 6, 2008

Bureau of Radiological Hea

lth

Cone-beam Units

NewTom 3G by AFP

I-CAT by ISI

Galileos by Sirona

3D Accuitomo
by J. Morita

MercuRay by Hitachi

Iluma by IMTEC

Effective dose (Sv)

Comparative Dosimetry

Source; Stuart White- UCL

A 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- UCL

A School of Dentistry

Cephalometric Analysis

Source; Stuart White- UCL

A 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- UCL

A 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- UCL
A School of Dentistry