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By Jennifer Garvin

Silver Spring, Md.—The U.S. Food and Drug Administration on July 28 issued its final regulation on dental amalgam, reaffirming the agency's position that the material is a safe and effective restorative option for patients.

The FDA said its decision was based on some 200 scientific studies of the material by government and independent organizations worldwide.

The new regulation classifies encapsulated dental amalgam and its component parts, elemental mercury and powder alloy, as class II medical devices. Previously there was no classification for encapsulated amalgam, and mercury and alloy were classified separately. This new regulation makes the classifications consistent and places encapsulated amalgam in the same class of devices as most other cavity-filling materials, including composite and gold fillings.

"The best available scientific evidence supports the conclusion that patients with dental amalgam fillings are not at risk for mercury-associated adverse health effects," said Dr. Susan Runner, acting director of the FDA's Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Center for Devices and Radiological Health, during a July 28 press conference with major media outlets.

The ADA has supported a class II designation for amalgam since the FDA first proposed it in 2002.

"The FDA has left the decision about dental treatment right where it needs to be—between the dentist and the patient," said Association President John S. Findley.

Dr. Runner added that the FDA also explored potential health effects of dental amalgam in developing fetuses, breast-fed infants and children under age six, and found that "the scientific evidence that is available suggests that these populations also are not at risk."

By making amalgam a class II device, the FDA can now impose special controls in a guidance document that contains recommendations on performance testing, device composition and labeling statements.

Specifically, the FDA is recommending that new product labeling include warnings for patients with mercury allergies and for using the product in ventilated areas. It is also recommending that manufacturers include a statement discussing the scientific evidence on the benefits and risks of amalgam to help dentists and patients make informed decisions about the use of dental amalgam.

"The proposed product insert underscores what the ADA has long recommended—a discussion between dentists and patients about the full range of treatment options to help patients make educated decisions regarding their dental care," Dr. Findley said.

As part of the settlement of a 2006 lawsuit, the FDA posted revised information on its Web site about dental amalgam and the agency agreed to set a definite deadline (July 28, 2009) to complete what it began in 2002.

The FDA currently has three classes of medical devices based on the level of risk (class I=lowest risk; class II=moderate risk; and class III=highest risk). Most devices that dentists use are either Class I or II.

To see the FDA's statement on its Web site, visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm .

The ADA has comprehensive information on ADA.org for both dental professionals and consumers regarding the safety of dental amalgam. To access this information, visit www.ada.org/prof/resources/topics/amalgam.asp.