No subject

M. Kevin O Carroll ocarroll at FIONA.UMSMED.EDU
Fri Jan 23 12:20:46 PST 1998


I received a call this morning from Dr. Alvin Arzt, whose e-mail address
is on the cc line above. His company is developing a root canal sealer
on which he wants to do clinical studies comparing their sealer to
conventional sealers. His company has developed a system whereby they can
digitize the radiographic image of the canal contents and remove them from
the image, so that the clinicians who are being asked to evaluate the
condition of the apices of treated teeth on radiographs can be blind as to
the nature of the endodontic material.

        He says that the FDA is requiring them to develop a whole new
digitization system, at a possible cost of $150,000 to digitize the whole
radiograph rather than what he had intended to do. He asked me if I could
identify individuals who could advise him if the FDA's requirement is
valid or necessary, as his company would prefer not to undergo that expense
unnecessarily.

        Would those with expertise in this area please respond directly to
Dr. Arzt? Thank you.

        Kevin.

 ============================================================================
                        Dr. M. Kevin O Carroll, Professor

Department of Diagnostic Sciences               Executive Secretary
University of Mississippi                       American Academy of Oral
and
School of Dentistry                               Maxillofacial Radiology
2500 North State Street                         P O Box 55722
Jackson MS 39216-4505                           Jackson MS 39296-5722

               Tel: (601) 984-6060  Fax: (601) 984-6086 or 6099
                       E-mail: ocarroll at fiona.umsmed.edu
 ============================================================================



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