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Is Your Dental Lab Outsourcing to Foreign Labs? Find Out

Reprinted from the July 2006 issue of the Illinois Dental News

Doctor, do you know where in the world that prosthesis came from? Each day in the dental practice, dentists use equipment and materials produced outside the United States, from handpieces to curing lights to amalgam to gloves and so on. It’s likely that dentists give little thought to the origin of those products, and in most cases the source is clear. “Made in China,” “Made in Taiwan,” or “Made in the USA” is stamped somewhere on the item or in the packaging.

However, when it comes to the dental prosthesis, the trusted dental lab across town may be sending dental cases around the globe. Yet, if the dentist is ultimately responsible for the “product” delivered to the patient, how does the dentist control the quality and materials delivered if those are manufactured not half a block away but half a world away—thanks to the ever expanding global marketplace?

It begins with checking the documentation and asking your dental lab a few simple questions, says Ricki Braswell of the National Association of Dental Laboratories. She emphasizes that labs are required by law to disclose to dentists if they are outsourcing to foreign dental laboratories. “Dental laboratories are held to disclosure laws just as all manufacturers in the United States.” The U.S.-based laboratory must indicate point of origin in the following manner: 1) “Manufactured by XYZ Dental Laboratory, Shanghai, China or 2) “Distributed by XYZ Dental Laboratory, Anywhere, USA.” “The key words are ‘manufactured by’ or ‘distributed by.’ In essence, ‘manufactured’ indicates the laboratory location where the restoration was created,” notes Ms. Braswell. In addition, foreign dental laboratories are required to list on the invoice the 510(k) applications numbers of the dental materials they use to fabricate the case, which the dentist can confirm are FDA approved materials.

Moreover, dentists should ask their laboratories four specific questions to determine if the lab is outsourcing and if the lab is following the disclosure requirements mandated by the FDA:

1. Ask if the lab outsources any of the dental practice’s restorations to another laboratory. The answer should be a direct “yes” or “no.”
2. If the answer is “yes,” ask the lab if the cases are sent to a foreign or domestic laboratory.
3. If the laboratory is outsourcing to a foreign lab, the doctor should ask if the foreign lab registered with the FDA as an exporter and if the local laboratory they are using is registered with the FDA as an importer. The answer should be “yes” to both questions.
4. Finally, the doctor should request an affidavit stating that both labs are registered with the FDA including the registration numbers for both laboratories. The affidavit should also state that both laboratories are using only FDA approved materials.

The doctor can verify on-line whether the laboratories are registered with the FDA at http://www.fda.gov/cdrh/devadvice/341.html click on Online Search of Establishment Registration Records.

Ms. Braswell notes that NADL advocates full transparency and urges dental labs to make it very clear to dentists if cases are outsourced, but the law requiring such disclosure is relatively new. Consequently, some dental labs may be unaware that they are required to disclose this information as well as register with the Food and Drug Administration.

In addition to the FDA requirement, legislation passed in Illinois this spring requires dental laboratories to provide prescribing dentists information regarding the location where the laboratory work is preformed as well as the source and original location where materials used for dental appliances are obtained.

At the national level, the American Dental Association passed a resolution in 2005, Res. 83H-2005, directing the ADA to urge the U.S. Food and Drug Administration to require subcontracting dental laboratories to notify dentists in advance when prostheses, components, or materials indicated in the dentists’ prescription are to be manufactured or provided, either partially or entirely, by a foreign dental laboratory or any domestic ancillary dental laboratory.

It is estimated that 10-15% of the total number of U.S. restorations are produced in foreign countries. While it appears to be a sliver of the current dental marketplace, with the dwindling numbers of dental technician training programs and the increasing demand for esthetic dentistry the percentage of foreign-made dental restorations is likely to increase.

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