Regulatory Updates: Page 62

New Zealand seeks warnings on teeth whiteners
By DrBicuspid.com staff writers
The Environmental Risk Management Authority of New Zealand is seeking comments on proposed changes to the rules on the use of hydrogen peroxide as a teeth whitener.
December 8, 2010
Align Technology responds to FDA warning letter
By DrBicuspid.com staff writers
Align Technology received a warning letter from the U.S. Food and Drug Administration (FDA) on November 18 following an onsite inspection of Align's corporate headquarters between June 29 and August 9, 2010, and is now working to inform the agency of the steps it has taken in response to the warning letter, the company announced.
December 1, 2010
Infinitt gains FDA nod for simulation software
By DrBicuspid.com staff writers
Xelis Dental -- new simulation software from Infinitt that enables dentists and implantologists to conduct surgical planning -- has received U.S. Food and Drug Administration (FDA) clearance, the company announced.
November 28, 2010
EU to ban bisphenol A in baby bottles in 2011
By Reuters Health
BRUSSELS (Reuters) - The European Union (EU) will ban the use of organic compound bisphenol A (BPA) in plastic baby bottles from 2011 with the backing of a majority of EU governments, the EU's executive Commission said on Thursday.
November 28, 2010
Report: Dental mercury puts millions at risk
By DrBicuspid.com staff writers
A new report submitted by the International Academy of Oral Medicine and Toxicology to the U.S. Food and Drug Administration warns that mercury from dental amalgam restorations is putting millions of Americans at risk.
November 23, 2010
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VELscope Vx gains FDA clearance
By DrBicuspid.com staff writers
The VELscope Vx enhanced oral assessment system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and is now available for sale in the U.S., LED Dental announced.
November 22, 2010
NY Times raises concerns over dental cone-beam CT
By Kathy Kincade
Dental cone-beam CT proponents are overhyping the technology and underplaying the radiation risks, according to an article in the November 22 New York Times. But imaging experts say the real issue is professional judgment.
November 22, 2010
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FDA to require graphic warnings on cigarette packs
By DrBicuspid.com staff writers
Starting in 2011, the U.S. Food and Drug Administration (FDA) will require tobacco companies to include stronger warnings and graphic images on cigarette packages depicting the negative health consequences of smoking, including oral cancer.
November 9, 2010
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Align Technology gears up to enter China market
By DrBicuspid.com staff writers
Align Technology has received regulatory approval from the Chinese State Food and Drug Administration to market and sell the Invisalign system as a class II medical device for the treatment of malocclusion, the company announced.
November 4, 2010
Genesis implant system set for U.S. market
By DrBicuspid.com staff writers
The Genesis biomimetic implant system from Keystone Dental has received U.S. regulatory clearance, the company announced.
October 31, 2010
FDA issues safety alert for teething tablets
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) is warning consumers and healthcare professionals about teething tablets that may pose a risk to children.
October 24, 2010
Upgraded VELscope approved by Health Canada
By DrBicuspid.com staff writers
LED Dental's VELscope Vx Enhanced Oral Assessment system was granted a medical device license and approved for sale by Health Canada, the company announced.
October 19, 2010
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