"The U.S. Environmental Protection Agency (EPA) today proposed
standards under the Clean Water Act to help cut discharges of dental
amalgam to the environment. Amalgam is a mixture of mercury and other
metals that dentists use to fill cavities. Mercury is discharged when
dentists remove old fillings or remove excess amalgam when placing a new
filling.
Studies show about half the mercury that enters Publicly Owned
Treatment Works (POTWs) comes from dental offices. Mercury from amalgam
can then make its way into the environment in a number of ways,
including through discharge to water bodies. Contact with some
microorganisms can help create methylmercury, a highly toxic form of
mercury that builds up in fish, shellfish and fish-eating animals. Fish
and shellfish are the main sources of human exposure to methylmercury..."
Mercuty discharges from dental offices
Showing posts with label dentistry. Show all posts
Showing posts with label dentistry. Show all posts
Friday, September 26, 2014
Wednesday, August 5, 2009
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 amalgan..."
"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 amalgan..."
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