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FDA expected to rule on dental amalgam

Washington—On July 27, the U.S. Food and Drug Administration is expected to rule on a classification for encapsulated amalgam.

The FDA does not currently classify encapsulated amalgam, although it does classify one component of encapsulated amalgam as a Class II device. In its notice of rulemaking, FDA proposed to classify encapsulated amalgam as a Class II device. What controls might be associated with that classification, if any, are not known at this time.

As part of the settlement of a 2006 lawsuit filed against the FDA by multiple plaintiffs, including the anti-amalgam group Moms Against Mercury, the FDA agreed to issue a classification of amalgam decision no later than July 28, 2009.

The ADA supports the FDA's decision to classify amalgam as a Class II device and based on extensive studies and scientific reviews of the material by government and independent organizations worldwide, believes that dental amalgam remains a safe, affordable and durable cavity filling choice for dental patients. For that reason, the Association submitted public comment on the FDA's proposed rulemaking urging the FDA not to require any warnings or restrictions on the use of amalgam.

"The ADA is confident the FDA's decision will be based on the weight of scientific evidence," ADA President John S. Findley said, "and the Association is ready to assist members and the public to understand whatever action the FDA takes."