CHICAGO--After years of review and scientific study, the U.S. Food and Drug Administration reaffirmed in a July 28, 2009, ruling that dental amalgam is a safe and effective dental restorative material, a position supported by the Academy of General Dentistry.
The FDA ruling reclassifies the mercury component of dental amalgam from a class I (low risk) to a class II (moderate risk) medical device, which places it in the same class as gold and composite fillings. This means the FDA can mandate special controls to help provide "reasonable assurance" of its safety and effectiveness.
The special controls include recommendations on performance testing, device composition, and labeling statements. Specific recommendations for product labeling include warnings against their use in patients with mercury allergies or in poorly ventilated areas and a statement that reviews the benefits and risks of using dental amalgam.
"The AGD has long supported amalgam as a safe and effective dental restorative material. The choice for restorative material is between the dentist and the prudent patient based on the treatment, needs and wants," said AGD president David F. Halpern, DMD, FAGD.
"We are pleased with this ruling today and will continue to encourage patients to talk with their general dentists about their concerns and questions related to dental amalgam and we will offer educated guidance as well as assure patients of its safety."
In 2002, the FDA issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use. The high volume of commentary received on the proposal spurred the agency to hold an advisory committee meeting in 2006 to review existing scientific data on dental amalgam.
AGD past president Vincent C. Mayher, DMD, MAGD, testified at the 2006 committee meeting on behalf of the AGD in support of using dental amalgam as a viable option to treat dental decay.
Most people recognize dental amalgams as silver fillings. Dental amalgam is a mixture of mercury, silver, tin and copper. Mercury, which makes up about 50 percent of the compound, is used to bind the metals together and to provide a strong, hard, durable filling.
After years of research, mercury has been found to be the only element that will bind these metals together in such a way that can be easily manipulated into a tooth cavity.
It is estimated that more than 1 billion amalgam restorations (fillings) are placed annually.
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