NEW YORK, USA/LEIPZIG, Germany: The US Food & Drug Administration (FDA) has given 510(k) clearance to iLase, the world's first hand-held dental laser from Biolase. The decision will give the California-based manufacturer the right to market their new product in the USA and other countries worldwide. Shares of the company went up over 20 per cent yesterday morning after the clearance was announced by the regulators.
FDA 510(k) clearance or Premarket Notification must be submitted by all manufacturers that wish to introduce Class 2 medical devices to the US. Biolase received the FDA's approval just after they introduced the iLase at the CDS Midwinter Meeting in Chicago in February. The company announced that they will start shipping the device in April.
As first self-contained dental laser on the market, iLase integrates the battery power, user interface and controls in one single pen-like handpiece with no foot pedals or cords attached. It comes equipped with Biolase's proprietary ComfortPulse control that allows tissue to cool between pulses for improved patient comfort, company officials said.
They added that the laser will be able to perform 25 FDA-cleared soft tissue and hygiene procedures including gingivectomies, sulcular debridement or the treatment of periodontal disease.
NEW YORK, NY, USA/LEIPZIG, Germany: The US government should review its existing amalgam regulations, an advisory panel of the Food and Drug Administration ...
LAKE FOREST, Ill., US: BIOLASE, the globally recognised leader in dental laser technology, has launched its state-of-the-art all-tissue laser system, ...
At the end of the 19th century, when researchers developed the first X-ray machine, they knew it posed potential danger. Due to leakage from X-ray tubes, ...
VANCOUVER, BC, CANADA/NEW YORK, USA: The 2010 Pacific Dental Conference will be held 15 to 17 April at the newly expanded Vancouver Convention Centre West ...
ANAHEIM, CA, USA: AMD LASERS, the company that builds the world’s most affordable dental laser technology, announces the launch of the Picasso soft ...
COLUMBUS, OH, USA: The 145th Ohio Dental Association (ODA) Annual Session will take place Sept. 15-18 (Thursday through Sunday) at the Greater Columbus ...
Yankee Dental Congress 36 will be held at the Boston Convention & Exhibition Center Jan. 26 to 30, Wednesday through Sunday. The exhibit hall will be ...
NEW YORK CITY: Columbia University’s College of Dental Medicine will host the First International Conference on Dental and Craniofacial Stem Cells ...
DENVER, Colo., USA: The Sixth International Congress on 3D Dental Imaging will be held Oct. 25-27 at the Inverness Hotel & Conference Center. The theme ...
BELLEVUE, Wash., USA: Modern Dental Laboratories has announced that registration for its second World Dental Forum in Hong Kong in 2012 is now open to ...
Live webinar
Thu. 18 July 2024
8:00 PM EST (New York)
Live webinar
Tue. 6 August 2024
6:00 PM EST (New York)
Live webinar
Tue. 13 August 2024
7:00 PM EST (New York)
Live webinar
Wed. 14 August 2024
12:30 PM EST (New York)
Live webinar
Wed. 21 August 2024
9:00 AM EST (New York)
Dr. Jim Lai DMD, MSc(Perio), EdD, FRCD(C)
Live webinar
Wed. 28 August 2024
8:00 PM EST (New York)
Live webinar
Mon. 2 September 2024
5:00 AM EST (New York)
To post a reply please login or register