FDA Issues Final Regulation on Dental Amalgam

The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.

The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.

Specifically, the FDA recommended that the product labeling include:

• A warning against the use of dental amalgam in patients with mercury allergy;
• A warning that dental professionals use adequate ventilation when handling dental amalgam;
• A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

For full article: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm

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Content on this blog are for informational purposes only, is neither intended to and does not establish a standard of care, and is not a substitute for professional judgment, advice, diagnosis, or treatment. ACES is not responsible for information on external websites linked to this website.

FDA Issues Poisonous Toothpaste Alert

The United States Food and Drug Administration has recently issued a toothpaste alert for people to avoid buying any toothpaste that is marked as made in China. An import alert, to prevent the tainted toothpaste from entering the United States, has been issued as well.

The FDA has provided a complete list of toothpaste brands that contain the deadly chemical, diethylene glycol.

This alert comes after diethylene glycol was found in Chinese toothpaste that was illegally imported from Panama into the Dominican Republic in May 2007. Diethylene glycol is used as a solvent in antifreeze and is also the chemical that is blamed for taking the lives of at least 51 Central Americans after it was found mixed with cough syrup last October.

For full article: http://dentistry.about.com/od/researchandstudie1/a/taintedtp.htm

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ACES is the world's leader in providing live webcast dental continuing education

Disclaimer

Content on this blog are for informational purposes only, is neither intended to and does not establish a standard of care, and is not a substitute for professional judgment, advice, diagnosis, or treatment. ACES is not responsible for information on external websites linked to this website.

FDA takes another look at mercury-based dental fillings

Although there are no new data on the safety of mercury alloy dental fillings, the Food & Drug Administration wants to know whether the methods used to ascertain their safety were adequate.

Last year the Food & Drug Administration ruled that the mercury-containing metal in dental fillings is safe, but the agency wants to know if the methods it used to determine the alloy's safety were satisfactory.

The FDA is holding a public meeting today and tomorrow on the issue, focusing on the risk of the dental amalgam for children and pregnant women.

For full article: http://www.massdevice.com/news/fda-takes-another-look-mercury-based-dental-fillings?source=http://www.dentalindia.com

Website supported by www.aces4ce.com
ACES is the world's leader in providing live webcast dental continuing education

Disclaimer

Content on this blog are for informational purposes only, is neither intended to and does not establish a standard of care, and is not a substitute for professional judgment, advice, diagnosis, or treatment. ACES is not responsible for information on external websites linked to this website.