Regulatory Updates: Page 70

FDA takes another look at acetaminophen
By DrBicuspid.com staff writers
The U.S. FDA is considering new guidance on products containing acetaminophen due to the danger of potential liver damage, according to an ADA News article.
July 5, 2009
Ohio lawmakers mull new hygienist regulation
By DrBicuspid.com staff writers
The Ohio Legislature is considering a bill that would create a new type of supervision for dental hygienists working outside the dental office.
June 23, 2009
Louisiana House passes mobile dentistry bill
By Laird Harrison
The Louisiana House of Representatives today passed a bill calling for tighter regulation of mobile dentistry. The amended bill falls short of the ban on dentistry in schools originally proposed by the Louisiana Dental Association -- so short that its chief opponent came close to declaring victory.
June 3, 2009
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DeCare Dental now part of Wellpoint
By DrBicuspid.com staff writers
With regulatory approvals now in hand, health insurance giant WellPoint has completed its $100 million acquisition of DeCare Dental.
April 23, 2009
FDA clears Biolase's ezlase for oral/facial pain relief
By DrBicuspid.com staff writers
The U.S. FDA has granted 510(k) marketing clearance to Biolase Technology's ezlaze diode laser system for therapeutic medical and dental applications, including temporary pain relief, the company announced.
April 16, 2009
FDA recalls Stryker's Custom Cranial Implant Kits
By DrBicuspid.com staff writers
The FDA has issued a Class 1 recall for Stryker's Custom Cranial Implant Kits because they could pose an imminent hazard to health, according to the company.
January 28, 2009
Invisalign gets new FDA labeling
By DrBicuspid.com staff writers
The U.S. FDA has cleared new labeling for Align Technology's Invisalign system, removing the permanent dentition limitation from the indications for use. In addition, certain conditions previously listed as contraindications will now be listed as precautions.
January 12, 2009
FDA approves new drug for moderate to severe pain
By DrBicuspid.com staff writers
The U.S. FDA has approved tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain in adults ages 18 years and older, according to an agency press release.
December 15, 2008
China Medicine expands into dental market
By DrBicuspid.com staff writers
China Medicine of Guangzhou, China, announced it received approval from the Guangdong Food and Drug Administration to distribute dental equipment and instruments in Guangdong Province.
December 14, 2008
Lawsuit puts imported dental work under scrutiny
By Kathy Kincade
An Ohio woman has filed a malpractice lawsuit against a large, multistate dental practice and two of its dentists, charging that dental restoration products allegedly imported from China have left her permanently injured and disabled.
December 9, 2008
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'Super strong' titanium implant gains FDA clearance
By DrBicuspid.com staff writers
The U.S. FDA has granted 510(k) clearance to Manhattan Scientifics to market the company's "super strong" titanium metal dental implants, according to the company.
December 8, 2008
Align Technology can now market Invisalign in Japan
By DrBicuspid.com staff writers
Align Technology has received regulatory approval from Japan's Ministry of Health, Labour and Welfare to promote and sell its Invisalign brand in the country, according to the company.
December 7, 2008
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