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AcceleDent System From OrthoAccel Technologies, Inc. Secures Medical Device Regulatory Clearance to Market in Australia
Date:11/11/2009

HOUSTON, Nov. 11 /PRNewswire/ -- OrthoAccel Technologies, Inc., developers of the AcceleDent System, which is an acceleration device to enhance orthodontics, announced that its application to market and distribute the product for sale was approved by Australia's Therapeutic Goods Administration (TGA). AcceleDent is classified as an, "orthodontic appliance system," in Australia.

(Photo: http://www.newscom.com/cgi-bin/prnh/20091111/DA09142)

(Logo: http://www.newscom.com/cgi-bin/prnh/20091029/DA01250LOGO)

AcceleDent is a simple, removable dental device that patients wear in the mouth for twenty minutes daily. It generates a light microvibration force which modulates the bone tissue remodeling process and accelerates orthodontic tooth movement. The device is hands-free and allows the user flexibility to carry out most routine tasks during the twenty-minute use session. The first case in private practice was initiated last month in the United Kingdom, OrthoAccel's first commercial market.

Brent Tarver, VP Clinical Affairs at OrthoAccel, remarked, "We consider this regulatory clearance to be an important part of our strategic plans, particularly as we begin focusing on the conclusion of the pivotal trial next year for FDA clearance here in the United States." AcceleDent has been added to the Australian Register of Therapeutic Goods (ARTG). Mike Kaufman, VP Business Development at OrthoAccel, added, "We will be attending the World Federation of Orthodontists 7th International Orthodontic Cong
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SOURCE OrthoAccel Technologies, Inc.
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