Regulatory Updates: Page 60

FDA tells denture adhesive makers to address zinc risks
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) is asking manufacturers of denture adhesives to take a more proactive role in informing consumers about the risks of zinc poisoning posed by some denture adhesive products.
February 27, 2011
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FDA clears 1st image review app for iPads, iPhones
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has issued 510(k) marketing clearance for MIM Software's Mobile MIM application, the first mobile image viewing application to receive clearance for diagnostic use on Apple's iPhone and iPad devices.
February 9, 2011
FDA launches medical device innovation initiative
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) is hoping to streamline the development and commercialization of new medical devices through a new initiative dubbed Innovation Pathway, a priority review program for new, breakthrough medical devices.
February 7, 2011
CDC's oral health division on the chopping block?
By Rob Goszkowski
The dental community is up in arms over a proposal by the U.S. Centers for Disease Control and Prevention (CDC) to fold its Division of Oral Health into the Division of Adult and Community Health, saying it will dilute the government's efforts to improve pediatric oral health.
February 6, 2011
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FDA calls for review of TMJ implants
By DrBicuspid.com staff writers
The U.S. Food and Drug Administration (FDA) has ordered three manufacturers of temporomandibular joint (TMJ) implants to conduct postmarket surveillance studies to determine the length of time before the implants are removed or replaced due to pain or other reasons.
February 6, 2011
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Mass. says kids' Medicaid dental program has improved
By DrBicuspid.com staff writers
A federal judge in Boston has ended a five-year, court-ordered oversight of the state's Medicaid dental program for low-income children after the program demonstrated significant improvement in the delivery of those services, according to a story in the Boston Globe.
February 3, 2011
Tenn. legalizes Botox use for oral surgeons
By Rabia Mughal
The Tennessee dental board has approved the use of Botox injections by oral and maxillofacial surgeons and considerations are under way that might allow general dentists to use the drug in the future.
February 3, 2011
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U.S. Senate supports repeal of 1099 provision
By DrBicuspid.com staff writers
The U.S. Senate on February 2 voted 81-17 to approve an amendment to repeal the so-called "1099 provision," which requires American businesses to file a form with the Internal Revenue Service for every vendor with which they conduct transactions worth $600 or more.
February 2, 2011
FDA OKs hearing device that transmits sound via teeth
By DrBicuspid.com staff writers
Sonitus Medical has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its SoundBite hearing system, a removable hearing prosthetic that transmits sound via the teeth.
January 26, 2011
U.S. FDA unveils device changes, defers big issues
By Reuters Health
WASHINGTON (Reuters) - The U.S. Food and Drug Administration (FDA) unveiled steps aimed at streamlining the approval process used for most medical devices but deferred decisions on the most contentious issues.
January 19, 2011
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FDA warns Dentsply about advertising violations
By Rob Goszkowski
In what is being characterized as "serious" violations, the U.S. Food and Drug Administration has issued a warning letter to Dentsply for misbranding its localized anesthetic Oraqix in a journal ad and professional mailers.
January 18, 2011
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Mich. health agency keeps eye on CT purchases
By DrBicuspid.com staff writers
A health planning agency in Western Michigan is considering a request for a dental CT scanner from a Mecosta County dental practice. If approved, it would become the seventh dental CT scanner in use in Western Michigan, according to a story in the Michigan Business Review.
January 17, 2011
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