Are Your Dental Products Manufactured Offshore?

6/07/06

Many of the traditional products found in dental operatories, such as cements, handpieces, curing lights, amalgam, and gloves are manufactured outside of the United States borders. Dentists may not always be making the choice they think they’re making when contracting dental laboratory services. The ADA is seeking to change that.

In Resolution 83H-2005, the ADA House of Delegates called for the Association to urge the FDA to require that a subcontracting dental laboratory notify the dentist in advance when prostheses, components, or materials indicated in the dentist’s prescription are to be manufactured or provided either partially or entirely by a foreign dental laboratory or any domestic ancillary dental laboratory.

The Council on Dental Practice believes it’s important for dentists to know where a case will be fabricated and where the materials are coming from prior to its delivery, so that dentists can use that information in selecting a dental laboratory.

“It’s absolutely critical for a dentist to know not only the skills and qualifications of their own staff, but also those they assign work to outside of their office,” says Gordon Isbell III, chair of the ADA Council on Dental Practice. “Since every treating dentist has responsibility for every aspect of the care their patients receive, it’s imperative that when a dentist provides a prescription for a prosthetic device the dentist knows that the quality and materials are exactly what was expected. That means knowing both who will make a device as well as where it will be made.”

In the June 2005 issue of the Journal of the American Dental Association, Gordon J. Christensen, DDS, and co-author William Yancey, DDS, outline potential solutions to the challenges facing the dental lab industry: only materials for which manufacturers have completed a premarket notification 510(k) of the FDA should be used in prostheses and the National Association of Dental Laboratories should encourage laboratories using prostheses made offshore to require materials to be specified and identified.

“The dental profession and the dental laboratory industry should encourage and support the FDA to carry out their requirements,” says Christensen. “The ADA and state dental societies should lobby for legislative support in enforcing requirements and regulations for products made offshore.”

[www.ada.org]