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"Over the years, our customers have demonstrated that many different typesof malocclusion can be effectively treated with Invisalign," said Thomas M.Prescott, president and CEO. "Their clinical successes, along with ourmanufacturing and process improvements, have enabled us to amend our productlabeling to reflect this broader applicability."
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"Today, doctors are offering Invisalign primarily to adults and teens.This change is an important step towards facilitating our long term goal ofmaking Invisalign the preferred orthodontic treatment option for patients ofall ages and for more severe types of malocclusion," said Dr. Eric Kuo, vicepresident of clinical technology.
In 1998, the FDA cleared the Invisalign system for use in patients withpermanent teeth and contraindicated the device for patients presenting withmixed dentition, severe overbite, severe overjet, tooth malocclusion requiringsurgical correction, adolescent patients with a skeletally narrow jaw, andadult patients with dental prosthetics/implants. The recently clearedlabeling change was made based on a better understanding of the broaderapplications of the Invisalign system, advances in Align's manufacturingcapabilities, and advances in the current practice of orthodontic treatmentbeing administered by doctors using the Invisalign system. For moreinformation on the expanded labeling for the Invisalign system, please referto Align's 510(k) Premarket Notification located on the Company's investorrelations section of its website: http://investor.aligntech.com.
About Align Technology, Inc.
Align Technology designs, manufactures and markets Invisalign, aproprietary 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 limitationsassociated with braces. Invisalign is appropriate for treating adults andteens. Align Technology was founded in March 1997 and received FDA clearanceto market Invisalign in 1998. Today, the Invisalign product family includesInvisalign, Invisalign Teen, Invisalign Assist, Invisalign Express, and ViveraRetainers.
To learn more about Invisalign or to find an Invisalign-trained doctor inyour area, please visit http://www.invisalign.com or call 1-800-INVISIBLE.Investor Relations Contact Shirley Stacy Align Technology, Inc. (408) 470-1150 [email protected] Press Contact Shannon Mangum Henderson Ethos Communication, Inc. (678) 540-9222 [email protected]
SOURCE Align Technology, Inc.
