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Regulatory Updates: Page 77
Splintek's dental guard gains FDA approval
By
DrBicuspid.com staff writers
Splintek recently announced that its SleepRight dental guard has received over-the-counter marketing clearance from the U.S. FDA.
June 29, 2008
FDA to reclassify amalgam by July 2009
By
DrBicuspid.com staff writers
The FDA has announced that it will reclassify dental amalgam by July 2009. This deadline has been set as part of a settlement between the FDA and the consumer group Moms Against Mercury.
June 22, 2008
California hygienists get independent regulating body
By
DrBicuspid.com staff writers
Gov. Arnold Schwarzenegger signed legislation last week that made California the first state to establish a self-regulating agency for dental hygienists.
June 16, 2008
ADA seeks clarification from FDA on amalgam comments
By
DrBicuspid.com staff writers
The ADA is expressing concern about recent statements from the FDA suggesting that the agency has already decided to mandate some form of special labeling for dental amalgam as a caution to groups purportedly sensitive to mercury.
June 15, 2008
Amalgam ban unlikely, new warnings possible
By
Laird Harrison
The recent FDA decision on amalgam could have huge repercussions for dentists -- or almost none. Amalgam opponents describe it as the beginning of the end for the dental treatment they hate. The ADA portrays the change as a bureaucratic reshuffling. The truth probably lies in the middle.
June 10, 2008
FDA revises its position on dental amalgams
By
Kathy Kincade
The FDA has settled a lawsuit that sought to have mercury fillings banned from the U.S. market. While not agreeing to a ban, the agency has agreed to add warnings regarding the use of amalgams in some patient groups, and to complete a review that could lead to more stringent regulation of the substance.
June 4, 2008
Local anesthetic-reversal drug approved
By
Laird Harrison
The FDA has approved the use of phentolamine mesylate as the first-ever drug for reversing local anesthesia, Novalar Pharmaceuticals announced May 12. The company, which holds a patent on this use of phentolamine, plans to begin marketing the drug at the annual ADA meeting in October under the name OraVerse.
May 11, 2008
Facing lawsuit, FDA reviews amalgam
By
Salley Shannon
Should pregnant women and parents of small children be warned against amalgam restorations? Should dental assistants, or dentists themselves? After tussling with such questions periodically since 1980, the FDA is once again asking for public comments.
May 6, 2008
FDA reconsiders amalgam; how to stop embezzlement
By
Laird Harrison
May 6, 2008
Cardinal Health mouthwash recalled
By
DrBicuspid.com staff writers
Hydrox Labs and Cardinal Health have recalled their Cardinal Health alcohol-free mouthwash because it has tested positive for infection-causing bacteria.
May 6, 2008
FDA requests comments on amalgam
By
DrBicuspid.com staff writers
Attention mercury skeptics! It is open season on dentistry's oldest bogeyman as the FDA has opened a 90-day comment period on its classification of amalgam alloy, encapsulated amalgam alloy, and dental mercury.
April 28, 2008
FDA approves new latex gloves
By
DrBicuspid.com staff writers
Dentists whose gloves irritate their hands got some good news April 23 when the FDA approved gloves made from a new type of latex.
April 28, 2008
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