Navigation Links
FDA Clears Expanded Labeling for the Invisalign System
Date:1/12/2009

SANTA CLARA, Calif., Jan. 12 /PRNewswire-FirstCall/ -- Align Technology, Inc. (Nasdaq: ALGN) today 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 applicability."

"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. The recently cleared labeling change was made based on a better understanding of the broader applications of the Invisalign system, advances in Align's manufacturing capabilities, and advances in the current practice of orthodontic treatment being administered by doctors using the Invisalign system. For more information on the expanded labeling for the Invisalign system, please refer to Align's 510(k) Premarket Notification located on the Company's investor relations section of its website: http://investor.aligntech.com.

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, the Invisalign product family includes Invisalign, Invisalign Teen, Invisalign Assist, Invisalign Express, and Vivera Retainers.

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

     Investor Relations Contact
     Shirley Stacy
     Align Technology, Inc.
     (408) 470-1150
     sstacy@aligntech.com

     Press Contact
     Shannon Mangum Henderson
     Ethos Communication, Inc.
     (678) 540-9222
     align@ethoscommunication.com

'/>"/>
SOURCE Align Technology, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. FDA Clears the DPL (Deep Penetrating Light) Therapy System for Over-the-Counter - Home Use
2. FDA Clears NeuroStar(R) TMS Therapy for the Treatment of Depression
3. Dutch Authorize Manufacture of Vaccinogens New Cancer Vaccine; License Clears Path to European Production, Final FDA Trial
4. Genetic Information Nondiscrimination Act clears Senate
5. Alzheimers vaccine clears plaque but has little effect on learning and memory impairment
6. ClearScript Offers Innovative Medication Therapy Management Program to Employee Health Plans
7. FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring Metastatic Prostate Cancer Patients
8. Congress Clears the Way for National CPR and AED Awareness Week
9. American Medical Association Clears Path for Adenoviral Conjunctivitis - Pink Eye - Detector
10. FDA Clears MDN-CGS(R) Intravenous Insulin Dosing Software
11. Global Gene Map Clears New Milestone
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... ... industry today announced its strategic partnership with Connance, a healthcare industry leader ... two companies’ proven, proprietary technology combine to provide health systems, hospitals and ...
(Date:6/26/2016)... ... , ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect ... a whole new perspective by using the title layers in ProSlice Levels to ... ProSlice Levels contains over 30 Different presets to choose from. FCPX users ...
(Date:6/25/2016)... TX (PRWEB) , ... June 25, 2016 , ... Austin ... of the American College of Mohs Surgery and to Dr. Russell Peckham for medical ... and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/24/2016)... ... June 24, 2016 , ... June 19, 2016 is ... associated with chronic pain and the benefits of holistic treatments, Serenity Recovery Center ... suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a disorder of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 Roche ... received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) ... severe sepsis or septic shock. With this clearance, Roche ... provide a fully integrated solution for sepsis risk assessment ... associated with bacterial infection and PCT levels in blood ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... to their offering. The ... commercial environment for MedImmune to enter. The US ageing population ... to drive considerable growth for effective anti-influenza medications. The introduction ... considerably, but development is still in its infancy. ...
(Date:6/23/2016)... and INDIANAPOLIS , June ... receiving a Lilly Diabetes Tomorrow,s Leaders Scholarship is any ... scholarship winners, announced today online at www.diabetesscholars.org ... type 1 diabetes stand in the way of academic ... supported the Foundation,s scholarship program since 2012, and continues ...
Breaking Medicine Technology: