Dental Laboratory Association Informs Patients of Potential Lack of Regulation for Dental Restorations

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According to The Regulatory Side of Sleep Devices, the FDA regulates sleep device manufacturing labs yet other dental devices and restorations go unregulated. It is the responsibility of the dental lab and dentist to ensure regulatory compliance for the safety of the patient, but patients must also be aware of this issue and take health into their own hands.

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Photo of NADL member Heather Voss, CDT, by Kate Lovering

A dental laboratory technician is rarely seen by the patient, yet is always in the foreground of a successful device

The Food and Drug Administration began regulating medical dental devices in 1994, requiring sleep device manufacturing labs to be FDA-registered, outsourcing to be done with full and proper disclosure and materials to be FDA-registered and accepted, according to The Regulatory Side of Oral Sleep Devices. Yet, other dental devices and restorations – such as crowns and bridges – go unregulated and into patients’ mouths.

“A dental laboratory technician is rarely seen by the patient, yet is always in the foreground of a successful device,” says Laura Sheppard, owner and managing member of Device Masters Dental Laboratory and National Association of Dental Laboratories (NADL) board of directors member. These technicians are the manufacturers of sleep devices and dental restorations.

Unlike the EU, U.S. dental lab technicians are not required to have a formal education, specific training or demonstrate core competency. Some labs are unaware or misinformed, do not have quality systems in place, are not registered or don’t follow regulatory requirements. Many dentists also are unaware of these requirements. It is the joint responsibility of the lab and the dentist to ensure regulatory compliance for the safety of the patient.

“We all know that healthcare should be offered with the best and safest services possible,” says Sheppard. “Dentists and laboratories alike must do their best to become informed and act accordingly to provide the highest level of medical device service for their patients.”

Patients have the right to know where their restorations are from and the qualifications of the business that made the restoration. NADL’s campaign,“What’s In Your Mouth?” suggests patients assess the quality of their restorations by asking their dentists these four basic questions:

1. “Do you use a Certified Dental Technician for your laboratory work?”
2. “Is the laboratory you work with certified and by whom?”
3. “Where is your dental laboratory located?”
4. “What patient contact materials are in the restorations you are prescribing for the treatment plan?”
5. “How does your dental practice ensure that it is not using misbranded or grey market dental implant parts?”

About NADL:
The National Association of Dental Laboratories is the unified voice of the dental laboratory profession supporting dentistry and serving the public interest by promoting high standards. NADL accomplishes this by providing programs, services and networking opportunities to meet the evolving technical, educational, professional and business needs of dental laboratories. http://www.nadl.org

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Brianna Barnebee
@WIYM_NADL
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