Author: FDA News

Source: Daily Device Bulletin

Year: 2008

Comment:

While this article shows that FDA agreed to classify dental amalgam by July 28, 2009, it also reports, "In 2002, agency staff said the failure to classify mercury amalgam was 'inadvertent' but later withdrew that claim, the suit said."

Abstract / Excerpt:

“As part of a settlement in a lawsuit filed by Moms Against Mercury, the FDA has agreed to classify a controversial mercury-containing cavity filler by July 28, 2009.  The agency proposes to classify dental amalgam made of liquid mercury and metal powder as a Class II device. This would enable the agency to impose special controls to ensure the product’s safety and effectiveness.”

Citation:

FDAnews.  FDA to classify mercury fillings by summer 2009.  Daily Device Bulletin.  June 17, 2008. 5(118):1. http://www.fdanews.com/newsletter/article?issueId=11684&articleId=107723.