For more than a year, the news media have produced stories questioning the safety of imported consumer goods ranging from children’s toys to food for pets and humans. These news items typically report that random tests uncovered contaminants, such as gluten, lead or agricultural chemicals. Separate investigations by U. S. government agencies quickly led to product recalls  to protect consumers.
Several news outlets reported concern over the safety of some imported dental materials, such as dental crowns. Some news reports subjected foreign made dental crowns to laboratory testing and indicated that lead had found at a level of approximately 200 parts per million (ppm).
The ADA takes action
After the first news segment aired, the American Dental Association notified federal agencies, including the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control (CDC), as well as other dental organizations and the nation’s dentists.
“Dentists, like physicians, have one thing in mind: their patients’ health, safety and personal well-being,” said ADA President Dr. Mark Feldman.
The ADA began its own investigation and is conducting tests of both foreign and domestically produced dental crowns at its laboratories in Chicago and Gaithersburg, MD. The ADA will share its research findings with government agencies, the dental profession and the public.
The ADA asked the CDC, which has extensive expertise in the area of lead exposure, to address any safety concerns with lead in dental crowns and bridges.
The CDC responded that 200 ppm (the approximate amount of lead reportedly found in the crowns featured in the initial news report), is “highly unlikely” to cause adverse health effects.
What’s made where?
A small number of dental offices in the United States have their own laboratories on the premises. Most dental offices, however, rely on independent dental laboratories to use the dentist’s “impressions” or “molds” to craft the custom-made crowns, bridges and other dental restorations (called a dental prosthesis) that are unique to each patient.
There are thousands of dental laboratories across the United States, ranging from very small 1- or 2-person operations to some that have more than 100- employees. Some domestic dental laboratories outsource a portion of their work to foreign laboratories.
Outsourcing may be done for various reasons: a local laboratory may be too busy to handle all of the orders it receives especially during peak periods of production, the work may be outsourced to expedite a request or to lower the cost to the dental laboratory.
Who watches out for consumers?
Just as some medical devices and drugs are imported from other countries, some dental products, from toothpaste to dental office materials, also are imported.
The U.S. Food and Drug Administration is responsible for overseeing the safety and effectiveness of many of these products. This includes drugs and medical devices that are marketed in the United States, whether they are manufactured in domestic or foreign establishments.
As such, the FDA regulates the material used in the construction of crowns, bridges, and other devices commonly fabricated by dental laboratories.
The U.S. Customs Border Protection and the FDA work together to ensure that imported devices comply with federal regulations. The FDA takes allegations about all potentially unsafe products very seriously and is currently investigating claims about imported dental materials.
The ADA: Protecting consumers
The American Dental Association’s laboratories in Chicago also have begun investigating the safety of both foreign and domestically produced dental crowns and other dental prostheses.
The ADA will share its findings with government agencies, the dental profession and the public.
What you can do:
The quality and the safety of dental materials you receive should matter most, more so than which dental laboratory produces the work. How can you be assured of what you are getting? Here are some questions you can discuss with your dentist:
- Do you fashion your own crowns, bridges, and other dental materials in the office or purchase them from a dental laboratory?
- Where is the dental lab located?
- Does the laboratory outsource crowns or bridges to a foreign country?
- What materials are going to be used in my restoration?
- What other options do I have?
You can find out more about dental materials on the ADA’s Web site. Discussing your oral health concerns with your dentist is the most important thing you can do. We encourage you to bookmark our Web site www.ada.org—your trusted resource for good oral health. |
