ADA Press Release
CDC, FDA Weigh In on Safety Concerns with Dental Crowns
CHICAGO (April 29, 2008)—The American Dental Association (ADA) appreciates the responses from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) addressing safety concerns raised by media reports about lead in dental prostheses such as crowns and bridges.
According to the CDC, trace amounts of lead at a level of 200 ppm, such as the amount the one Ohio news outlet reportedly found in several dental crowns, are “extremely unlikely to cause adverse health effects.” The CDC also states that given the current information at hand, they do not recommend that individuals defer needed dental treatment or have existing dental crowns, bridges or other prostheses removed.
“We are glad that the CDC sees no threat to patients based upon the trace amount of lead reported,” said ADA President Mark Feldman, D.M.D. “We are still conducting our own test of dental prostheses and will take the CDC up on its offer to evaluate the results."
When the story broke in February, the ADA notified the CDC (Letter 1, Letter 2) and the FDA (Letter 1, Letter 2) and asked the agencies to address any safety concerns. The FDA regulates the materials used to make dental crowns and bridges, and the CDC has extensive information and expertise in the area of lead exposure.
According to the CDC’s response, "Many consumer products contain lead in trace amounts, and federal regulations limit the amount of lead in consumer products" based on "the way the body absorbs lead, the potential hazard, and the lead level product manufacturers can achieve using good manufacturing practices…"
The ADA is testing both foreign- and domestic-made dental crowns to determine:
- The degree to which lead may be present;
- Where the lead may be located (i.e., in the metal alloy, the porcelain, etc.); and
- How much, if any, lead may be released from dental crowns.
Once testing is completed, the ADA will share the research findings with the dental profession, the public and the regulatory agencies responsible for protecting the public's health. However, this investigation should not be viewed as a substitute for necessary oversight and enforcement by the federal and state government agencies responsible for protecting the public’s health and safety.
The ADA encourages patients to discuss any concerns about the safety of their dental crowns or other prostheses with their dentists and will continue to share information on this issue.
About the American Dental Association
The not-for-profit ADA is the nation's largest dental association, representing 157,000 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 www.ada.org. For more information on oral health, including prevention, care and treatment of dental disease, visit the ADA’s consumer website www.MouthHealthy.org.