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:4/25/2017)... ... April 25, 2017 , ... As President Trump challenges ... for how his administration could impact the employee benefits industry. James Slotnick, AVP, ... most likely to make it through Congress. His discussion will focus on the ...
(Date:4/25/2017)... ... 25, 2017 , ... Lake Park Dental is now accepting new patients with ... Lutz, FL. With the help of this highly-effective, yet convenient system, patients can straighten ... discretion and less pain. , Drs. Sarah Jockin, Nicole Morganti, Sara Spear and ...
(Date:4/25/2017)... ... 2017 , ... As Spring reignites vigilance against Zika virus-carrying ... Zika virus during pregnancy, as well as other prenatal exposures like cocaine, are ... The Teratology Society is an international and multidisciplinary group of scientists ...
(Date:4/25/2017)... ... ... Saad B. Chaudhary, MD is committed to providing the highest quality of spine care to ... preventative care with all my patients to alleviate possible future issues. I am pleased to ... my office and my trained staff will assist you in any way possible.” , Dr. ...
(Date:4/25/2017)... , ... April 25, 2017 , ... There is no ... Hospital, according to a special report in the May issue of Consumer Reports focused ... highest quality ranking for results achieved during and after coronary bypass and aortic valve ...
Breaking Medicine News(10 mins):
(Date:4/20/2017)... 20, 2017 Research and Markets has ... Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, ... their offering. ... pharmacogenomics market was valued at US$ 7,167.6 Mn in 2015, ... expanding at a CAGR of 5.6% from 2016 to 2024. ...
(Date:4/19/2017)... , April 19, 2017 /PRNewswire/ - CRH Medical Corporation (TSX: CRH) (NYSE ... Bloom Burton & Co. Healthcare Investor Conference 2017 at the Sheraton ... Edward Wright , Chief Executive Officer of the Company is scheduled ... CFO, Richard Bear and the Chairman of the Board, ... ...
(Date:4/19/2017)... Global Surgical Drainage Device Market: Overview ... remove excess liquid and air. The fluid to be ... lymph. Surgical drains are used in a wide variety ... cardiovascular surgery, neurosurgery, plastic surgery etc. Common use of ... of fluid e.g. blood or pus. Surgical drains are ...
Breaking Medicine Technology: