Healthcare Industry News:  dental laser 

Devices Dental FDA

 News Release - March 19, 2008

BIOLASE Announces FDA 510(k) Clearance of Its Waterlase(R) and Waterlase(R) MD Laser Systems for Root Canal Disinfection

First Lasers Cleared for Adjunctive Disinfection for Root Canal; 15 Million Procedures Performed Annually in the US

IRVINE, CA--(Healthcare Sales & Marketing Network)--Mar 19, 2008 -- BIOLASE Technology, Inc. (NasdaqGM:BLTI ), the world's leading dental laser company, announced today that its WaterlaseŽ and WaterlaseŽ MD laser systems became the first laser systems to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) for root canal disinfection after endodontic instrumentation. The global release of the new procedure, protocol and associated disposables will be introduced at the American Association of Endodontists (AAE) Annual Session being held April 9-12 in Vancouver, BC, and simultaneous at the World Clinical Laser Institute (WCLI) Taiwan Super Symposium being held April 11-13 in Taipei, Taiwan and other major markets including Germany and Spain.

Combined with past FDA clearances for obtaining access, cleaning and shaping, this clearance allows BIOLASE users to perform the complete root canal procedure using FDA cleared procedures.

Dr. James Jesse, D.D.S., Assistant Professor at Loma Linda University School of Dentistry, said that since the 1920s, sodium hypochlorite, or bleach, has been the principal chemical disinfectant for root canal treatment and that the overall root canal procedure has changed little in decades of dental advancements.

"Being able to use a laser that is safer, faster and more effective than conventional chemical disinfectants to treat a condition that affects tens of millions of individuals/year is a true advancement for our profession," said Dr. Jesse. "In my experience, practitioners can perform the root canal procedure with superior results using the laser and may save as much as 20 to 30 minutes per procedure -- a strong clinical and economic argument for using the technology."

Jake St. Philip, BIOLASE Chief Executive Officer, said, "Clinically, we have developed and can now market a technology that is a better way to eliminate or avoid the infections that cause painful toothaches in millions of patients. Commercially, this clearance is a significant milestone for BIOLASE -- in addition to strengthening our intellectual property, it provides our sales force, our North American distributor Henry Schein and international distributors around the globe with a powerful marketing advantage.

"Ultimately, worldwide adoption of dental lasers as a standard will accelerate on dentists' ability to use the laser daily in a broader range of applications," St. Philip continued. "More than 15 million root canal procedures are done annually in the US alone and are a large part of any dental practice and laser root canals provide benefit to both the doctor and patients, making it an important everyday commercial application."

A root canal is a treatment used to eliminate infection and save a tooth that is painful, badly decayed and infected. During a root canal procedure, the nerve and pulp is removed and the inside of the tooth is cleaned, disinfected and sealed.

About BIOLASE Technology, Inc.

BIOLASE Technology, Inc. (, the world's leading dental laser company, develops, manufactures and markets lasers and related products that advance the practice of dentistry and medicine. The Company's products incorporate patented and patent pending technologies designed to provide clinically superior performance with less pain and faster recovery times. BIOLASE's principal products are dental laser systems that perform a broad range of dental procedures, including cosmetic and complex surgical applications. Other products under development address ophthalmology and other medical and consumer markets.

This press release may contain forward-looking statements within the meaning of safe harbor provided by the Securities Reform Act of 1995 that are based on the current expectations and estimates by our management. These forward-looking statements can be identified through the use of words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates," "may," "will," and variations of these words or similar expressions. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks, uncertainties and other factors which may cause the Company's actual results to differ materially from the statements contained herein, and are described in the Company's reports it files with the Securities and Exchange Commission, including its annual and quarterly reports. No undue reliance should be placed on forward-looking statements. Such information is subject to change, and we undertake no obligation to update such statements.

Source: BIOLASE Technology

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