Navigation Links
FDA Clears Expanded Labeling for the Invisalign System

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:

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 or call 1-800-INVISIBLE.

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

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

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:
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... 25, 2016 , ... First Choice Emergency Room , the largest network ... the Medical Director of its new Mesquite-Samuell Farm facility. , “We are pleased ... location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... people are unfamiliar with. The article goes on to state that individuals are now ... of these less common operations such as calf and cheek reduction. The Los Angeles ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
(Date:6/24/2016)... Georgia (PRWEB) , ... June 24, 2016 , ... ... awards today at the Clinical Decision Making in Emergency Medicine conference in Ponte ... have authored journal articles published in Emergency Medicine Practice and Pediatric ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , June 23, 2016 Research and ... Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data derived ... Assessment of major trends with potential impact on the market ... of market segmentation which comprises of sub markets, regional and ...
(Date:6/23/2016)... PARK RIDGE, Ill. and INDIANAPOLIS ... caliber of students receiving a Lilly Diabetes Tomorrow,s Leaders ... hands. The 2016 scholarship winners, announced today online at ... refused to let type 1 diabetes stand in the ... Lilly Diabetes has supported the Foundation,s scholarship program since ...
(Date:6/23/2016)... Research and Markets has announced ... Analysis (United States, China, Japan, Brazil, United Kingdom, Germany, ... offering. Surgical Procedure ... planners, provides surgical procedure volume data in a geographic ... in-depth analysis of growth drivers and inhibitors, including world ...
Breaking Medicine Technology: