FDA Updates Consumer Advisory
January 28, 2015
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CHICAGO — The U.S. Food and Drug Administration (FDA) denied three petitions to ban or restrict dental amalgam. In doing so, FDA strongly reaffirmed its position that amalgam is a safe and effective dental material. As part of its response to the petitions, FDA thoroughly reviewed the current science and updated its consumer advisory on dental amalgam fillings Jan. 27 to more clearly reflect its position.
“The FDA continues to leave the decision about dental treatment right where it needs to be—between the dentist and the patient,” states ADA President Dr. Maxine Feinberg. “The ADA encourages dentists and patients to discuss treatment options to help patients make educated decisions regarding their dental care. I am very pleased that dentists and patients will continue to have access to the full range of safe and effective dental restorative materials and treatment options.
The FDA concluded in 2009 that dental amalgam was a safe and effective dental material and issued a final rule, which the ADA supported. The FDA categorizes encapsulated dental amalgam as a class II medical device, placing it in the same class as gold and tooth-colored composite fillings. The ADA has supported a class II designation for dental amalgam since 2002 when first proposed by the FDA.
Dental amalgam is a cavity-filling material made by combining mercury with other metals such as silver, copper and tin. Numerous scientific studies conducted over the past several decades, including two large clinical trials published in the April 2006 Journal of the American Medical Association, indicate dental amalgam is a safe, effective cavity-filling material. And, in its 2009 review of the scientific literature on amalgam safety, the ADA’s Council on Scientific Affairs reaffirmed that the scientific evidence continues to support amalgam as a valuable, viable and safe choice for dental patients.
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About the ADA
The not-for-profit ADA is the nation's largest dental association, representing 161,000 dentist members. The premier source of oral health information, the ADA has advocated for the public's health and promoted the art and science of dentistry since 1859. The ADA's state-of-the-art research facilities develop and test dental products and materials that have advanced the practice of dentistry and made the patient experience more positive. The ADA Seal of Acceptance long has been a valuable and respected guide to consumer dental care products. The monthly The Journal of the American Dental Association (JADA) is the ADA's flagship publication and the best-read scientific journal in dentistry. For more information about the ADA, visit ADA.org. For more information on oral health, including prevention, care and treatment of dental disease, visit the ADA's consumer website MouthHealthy.org