FDA Clears Expanded Labeling for Align Technology's (ALGN) Invisalign System

January 12, 2009 9:00 AM EST

Align Technology, Inc. (Nasdaq: ALGN) announced that the 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.

"Today, doctors are offering Invisalign primarily to adults and teens. This change is an important step towards facilitating our long term goal of making Invisalign the preferred orthodontic treatment option for patients of all ages and for more severe types of malocclusion," said Dr. Eric Kuo, vice president of clinical technology.

In 1998, the FDA cleared the Invisalign system for use in patients with permanent teeth and contraindicated the device for patients presenting with mixed dentition, severe overbite, severe overjet, tooth malocclusion requiring surgical correction, adolescent patients with a skeletally narrow jaw, and adult patients with dental prosthetics/implants.

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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.

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