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)... ... , ... "FCPX editors can now reveal their media with growing colorful split ... Austin - CEO of Pixel Film Studios. , ProSlice Color brings the split ... now reveal the media of their split screens with growing colorful panels. , ProSlice ...
(Date:6/26/2016)... ... 2016 , ... Quality metrics are proliferating in cancer care, and are derived ... eye of the beholder, according to experts who offered insights and commentary in the ... Care. For the full issue, click here . , For the American Society ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , ... Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , ... our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Global Blood ... biopharmaceutical company developing novel therapeutics for the treatment ... today announced the closing of its previously announced ... stock, at the public offering price of $18.75 ... offering were offered by GBT. GBT estimates net ...
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... Mass. and SAN CLEMENTE, Calif. , ... California -based mobile pulmonary function testing company, is now able ... PFT devices developed by ndd Medical Technologies , Inc. ... testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® ... , can get any needed testing done in the comfort ...
Breaking Medicine Technology: