FDA Acceptance Granted for ORTHO Implant
Friday , September  24, 2004

IMTEC Corporation announces that the U.S. Food and Drug Administration has accepted its application for approval of its new ORTHO implant line. J. Brad Vance, IMTEC’s Director of Regulatory Affairs/Project Coordinator, explained the FDA accepted the company’s ORTHO implant as a medical device indicated to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate orthodontic movement of teeth.  ORTHO, part of the company’s successful Mini-Dental implant system, is now approved to be utilized by orthodontists to provide orthodontic anchorage for the movement of teeth.  We were very excited that the FDA fast-tracked our application to manufacture and market one of our newest products, the IMTEC MDI ORTHO implant, Vance said. It was my responsibility to submit a design dossier, which includes clinical research, technical reports, and

applicable regulatory compliance paperwork, to the Center for Devices and Radiological Health of the United States Food and Drug Administration for approval. With IMTEC’s clean track record and our diligent maintenance of an audited quality system specific for the medical device industry, I was able to expedite the whole process. Vance went on to explain that not only is the IMTEC mini implant the first implant (and currently the only) to gain approval for long-term indications from the FDA, it is also one of the first mini implants to include orthodontic applications.  By utilizing this new treatment option, orthodontic headgear may become a thing of the past.

Mr. Vance explained that Doretta Anderson, IMTEC’s Vice President of Sales and Marketing, traveled to Chicago on September 23, 2004 with Dallas orthodontist, Jason B. Cope, D.D.S., Ph.D., an IMTEC consultant, to attend a seminar at the University of Illinois College of Dentistry.  At that time Dr. Cope presented a seminar on ORTHO implants to approximately 80 dentists and students.  Vance said that demand for the seminar was such that the university cancelled classes in order for dental students to attend the program.

Assessing the Chicago program, Anderson stated: The response to Dr. Cope’s ORTHO  seminar was incredible.  Dentists and students are very excited about the product because it could simplify and greatly improve the way they practice orthodontics.

Anderson went on to explain that the ORTHO implants provide orthodontic stabilization with minimally invasive surgical placement.  They can be placed quickly and efficiently, with little or no discomfort to the patient. Importantly, placement usually involves less than an and usually requires no incisions.

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