Align Technology Inc, San Jose, Calif, has received regulatory approval from the Chinese State Food and Drug Administration (SFDA) to market and sell the Invisalign system as a Class II medical device for the treatment of malocclusion.
The company also received its License of Medical Device Operation Enterprise (Enterprise License) from the Shanghai Food and Drug Administration, which allows the company to distribute Invisalign in China. Align expects to enter the new market in the second half of 2011.
China is estimated to have nearly half a million new orthodontic case starts each year, with a higher percentage of complex Class II and III malocclusion cases than in western countries. Most orthodontic treatment there is done within government-owned hospitals in major metropolitan cities. Rising consumer demand, however, has led to accelerated growth of private dental clinics.
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