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Cheap Products Are Plaguing Dental Industry

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By BENNETT NAPIER

Published: October 25, 2007

What's in your mouth?

From lead-painted toys and tainted pet food to toxic toothpaste, Americans have had to become wary of everyday products they always assumed were safe. Now, we must deal with one more product often imported from abroad that may pose a danger to public health: the millions of porcelain crowns, dentures and bridges that American dental patients have permanently seated in their mouths each year.

Dental-restoration products are dangerously under-regulated. Although dentists prescribe the type of device, the product is actually manufactured by a dental technician employed by a laboratory that could be located anywhere sin the world.

Thus, most patients have no idea where their restoration came from, who manufactured it, or even what it's made from. And due to growing pressure by dentists to cut costs and increase profit margins, much of the dental work Americans carry in their mouths is imported from countries such as China, Pakistan, the Philippines and India.

Often, these imported products are not tested, inspected or sterilized. Even for products manufactured within the United States, most domestic dental laboratories are exempt from registering with the Food and Drug Administration. These lax regulations allow potential bad actors to enter the system with little oversight or accountability.

In Florida this April, a Palm Beach County man was arrested in his garage, which was full of power tools, false teeth, putty and moldings, after he offered to repair a 67-year-old woman's dentures for the bargain basement price of $40. His alleged crime, however, was not manufacturing dental devices, but practicing unlicensed dentistry.

Across the country, such operations are common, yet they are shut down only if the operator is found to have practiced on a patient. That's because practicing dentistry without a license is a felony, while operating an unregistered dental laboratory - without any credentials - is not illegal.

That's why the National Association of Dental Laboratories - the leading trade group for the $5.5 billion U.S. dental-restoration products industry - has formally asked the FDA to protect patient safety and require that dentists label and disclose the source of dental devices to patients, ensuring all such products can be traced back to the laboratory that made them.

Bennett Napier is co-executive director of the National Association of Dental Laboratories and its affiliated certifying body, the National Board for Certification in Dental Laboratory Technology.

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