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