by Christine Nathe, RDH, MS
[email protected]
With the recent regulation from the Food and Drug Administration (FDA) that categorized encapsulated dental amalgam as a class II (moderate risk) medical device, placing it in the same class as gold and composite restoratives, it is a reminder of the federal government’s role (one of many) in dental care.
Specifically, the FDA recommended that the product labeling include:
- A warning against the use of dental amalgam in patients with mercury allergy.
- A warning that dental professionals use adequate ventilation when handling dental amalgam.
- A statement discussing the scientific evidence on the benefits and risks of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.
The FDA, which was established in 1906 and is headquartered in Rockville, Md., assures the safety of foods and cosmetics and the safety and efficacy of pharmaceuticals, biological products, and medical devices. It is responsible for the regulation of dental materials such as dental amalgams, dental equipment, and over-the-counter dental care products. Specifically, the FDA is part of the U.S. Department of Health and Human Services, which is the federal government’s agency for protecting the health of all Americans and providing essential human services. The HHS includes more than 300 programs that cover a wide spectrum of activities (see Box 1).
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