Regulatory Updates: Page 67

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
Canada declares BPA toxic, sets stage for more bans
By Reuters Health
OTTAWA (Reuters) - Canada has declared bisphenol A (BPA) to be a toxic chemical, prompting calls for far-reaching curbs on the industrial chemical that is used in everything from the linings of aluminum cans to coatings on electronic till receipts.
October 14, 2010
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SD to amend dental sedation rules
By DrBicuspid.com staff writers
The South Dakota Board of Dentistry is proposing to amend rules regarding sedation and advertising, according to the Academy of General Dentistry.
October 7, 2010
CMS criteria mean sleep apnea patients could lose CPAP benefits
By Reuters Health
NEW YORK (Reuters Health) - The Centers for Medicare and Medicaid Services (CMS) criteria for coverage of continuous positive airway pressure (CPAP) treatment may be too strict, a study in the October issue of Chest suggests.
October 6, 2010
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Orthovita gets FDA nod for grafting material
By DrBicuspid.com staff writers
Orthovita has received 510(k) clearance from the FDA to market Vitomatrix Bone Graft Substitute as a bone grafting material in certain dental procedures.
October 3, 2010
European regulators: Sugar-free gum reduces caries
By DrBicuspid.com staff writers
In response to an application by Wrigley, the European Food Safety Authority (EFSA) has approved a health claim that xylitol-, sorbitol-, and mannitol-based sugar-free chewing gum reduces the risk of caries.
October 3, 2010
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