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Align Technology, Inc.

FDA Clears Expanded Labeling for the Invisalign System

Published in MD Week, January 30th, 2009

Align Technology, Inc. (NASDAQ:ALGN) announced that the U.S. Food and Drug Administration (FDA) has cleared new labeling for the Invisalign system, thereby removing the permanent dentition limitation from the indications for use. In addition, certain conditions previously listed as contraindications will now be listed as precautions.

"Over the years, our customers have demonstrated that many different types of malocclusion can be effectively treated with Invisalign," said Thomas M. Prescott, president and CEO. "Their clinical successes, along with our manufacturing and process improvements, have enabled us to amend our product labeling to reflect this broader...

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