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IMTEC Corporation announced that it has been recently
granted acceptance for long-term use of its MDI
mini dental implant system in Canada. This acceptance
was awarded by The Medical Devices Bureau of Health
Canada in Ottawa after a rigorous application process.
J. Brad Vance of Ardmore, IMTEC's Director of Regulatory
Affairs and New Projects Coordinator said, "IMTEC
management and staff worked diligently to provide
the information that Health Canada requested that
included extensive clinical studies that substantiated
our company's claim that our mini-dental implants
should receive long-term approval. Health Canada
is the Canadian health agency that's equivalent
to the U.S. (Food and Drug Administration) and their
approval is a big step for us."
Company founder and board of director's chairman,
Dr. Ronald Bulard's patented O-Ball prosthetic head
and metal housings allow the MDI implant to act
like a ball and socket that hold dentures firmly
in place.
Bulard explained the company's implants were initially
approved in Canada for transitional or temporary
use only pending review of the company's request
for long-term approval.
Canadian denture patients who might be ineligible
candidates for conventional or larger dental implants,
due to health or economic reasons, now have the
benefit of having their dentures stabilized with
a minimally invasive office procedure.
"The long-term acceptance by the Ottawa office will
now allow IMTEC to market the MDI in Canada on a
long-term basis," Bulard said. "Canadian doctors
who buy our products can now legally inform their
denture patients that the MDI has been approved
by that country's health agency as a long-term device.
That's significant and completely changes our market
potential for the mini implant system."
IMTEC Corporation is a dental specialty products
company located in Ardmore. The company has full-service
marketing offices in Toronto, Canada, Frankfurt,
Germany, London, England, and Cuernevaca, Morelos,
Mexico. The company's Web site is www.imtec.com.
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