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).