Canada approves long-term use of IMTEC products - Dental Implant Press Releases

Canada approves long-term use of IMTEC products
Nov 9, 2004
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.