Regulatory Updates: Page 75

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
2008 11 25 12 52 48 587 Malpractice 70
'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
EFSA: Xylitol chewing gum reduces caries risk
By DrBicuspid.com staff writers
The European Food Safety Authority (EFSA) has come out in support of claims that chewing gum containing xylitol can help reduce the risk of caries.
November 23, 2008
FDA, ALD to host free symposium on dental lasers
By DrBicuspid.com staff writers
The U.S. FDA and the Academy of Laser Dentistry (ALD) will host a joint symposium on the uses of lasers and other light-based technologies in dentistry on December 8, 2008, at the FDA facility in Silver Spring, MD.
November 18, 2008
Minnesota hammers out regulations for superhygienists
By Rabia Mughal
A Minnesota health task force is drafting regulations for a new class of oral health workers whose job description will likely lie somewhere between that of a hygienist and a dentist. A May law mandated the creation of an oral health practitioner in Minnesota by January 1, 2011.
October 28, 2008
2008 08 14 09 28 46 88 000003074613 70
Pennsylvania board bars dentists from dating patients
By Kathy Kincade
New regulations regarding what constitutes "sexual misconduct" for Pennsylvania dental professionals have the state dental association up in arms. They say the rules are "onerous" and will hurt the recruitment of practitioners to a state that is already suffering a shortage.
October 26, 2008
2008 10 27 10 45 32 585 No Dating
Three Cadbury gums get ADA Seal of Acceptance
By DrBicuspid.com staff writers
Certain flavors of Cadbury's sugar-free chewing gums -- Trident, Dentyne Ice, and Stride -- have received the ADA Seal of Acceptance, according to a Cadbury press release.
October 19, 2008
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