updated 10/21/2010 4:16:07 PM ET 2010-10-21T20:16:07

SAN JOSE, Calif., Oct. 21, 2010 (GLOBE NEWSWIRE) -- Align Technology, Inc. (Nasdaq:ALGN) today announced that it 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. Align 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 begin commercial availability of Invisalign in the second half of 2011.

"This is a significant milestone and we are very excited about the opportunity and growth potential for Invisalign in China," said Richard Twomey, Align vice president of International. "With rising income levels, increased spending on discretionary items such as high-end luxury goods, and heightened focus on health and aesthetics, China is poised to be one of the fastest growing markets for orthodontics in the foreseeable future."

Over the past decade, the Chinese orthodontic market has grown steadily as the importance of dental health and personal appearance has increased among the general population of 1.4 billion. Today, 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 is done within government owned hospitals in major metropolitan cities; however, rising consumer demand has led to accelerated growth of private dental clinics.

"With over 1.3 million patients treated worldwide, Invisalign is a cutting-edge treatment technology that has been used by many doctors to treat a very broad range of malocclusion," said Professor Yanheng Zhou, Professor and Chair, Department of Orthodontics, Peking University School of Stomatology. "The time is right for Invisalign in mainland China."

"The market for private orthodontic treatment in China is one of the fastest growing dental segments," said Robert Zou, Founder and CEO, Arrail Dental. "We are very excited to be working with Align Technology to bring its world leading Invisalign clear aligner treatment to our clinics and prospective patients throughout the country."

About Align Technology, Inc.

Align Technology designs, manufactures and markets Invisalign®, a proprietary method for treating malocclusion, or the misalignment of teeth. Invisalign corrects malocclusion using a series of clear, nearly invisible, removable appliances that gently move teeth to a desired final position. Because it does not rely on the use of metal or ceramic brackets and wires, Invisalign significantly reduces the aesthetic and other limitations associated with braces. Invisalign is appropriate for treating adults and teens. Align Technology was founded in March 1997 and received FDA clearance to market Invisalign in 1998. Today, Invisalign is a globally-recognized brand, with treatment available through specially-trained doctors in more than 50 countries. The Invisalign product family now includes Invisalign Full, Invisalign Teen, Invisalign Assist, Invisalign Lite, Invisalign Express, Invisalign Anterior, and Vivera Retainers.

To learn more about Invisalign or to find an Invisalign trained doctor in your area, please visit www.invisalign.com or call 1-800-INVISIBLE.

About Peking University

Peking University is the largest dental school in China. It is a prestigious, comprehensive educational institution featuring stomatology and conducts teaching and research while providing clinical service and preventative care for the public.

About Arrail Dental

Arrail Dental, a leading Chinese dental service provider targeting the high-end market, has clinics covering the major metropolitan areas of Beijing, Shanghai and Shenzhen, with over 400 dental professionals.

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