Regulation of Laboratories/Technicians
In a July 2008 American Dental Association survey of its members on dental laboratory issues, more than one-third of dentists indicated that they believed dental technicians and laboratories are regulated or licensed. In fact, there are no states in the U.S. where technicians are required to be licensed. Only six states mandate any baseline technical competency for technicians, another five require the dental laboratory to register with the state. Florida, Kentucky, South Carolina, Washington and Texas set the baseline competency and continuing education requirements for dental technicians based on the certified dental technician (CDT) designation administered by the National Board for Certification in Dental Laboratory Technology. This is the only recognized certifying body for dental technicians by the ADA. (See chart below.)
With minimal regulation, and few training options available today, dental groups and DSOs need to know and understand who is producing their restorations. The person who served you a sandwich at lunch yesterday could very well be the “technician” producing your patients’ dental restoration today. For this reason, it is increasingly important that technicians prove their knowledge by pursuing and obtaining a Certified Dental Technician designation from the National Board for Certification. Dental groups and DSOs can and should seek to work with dental laboratories and technicians who have voluntarily chosen to verify their skills and knowledge against a national standard.
The National Association of Dental Laboratories (NADL) is continuing to work with state regulatory agencies throughout the U.S. to set minimum operating standards within dental practice acts. Just this year, Washington state passed legislation introducing registration and certification requirements for dental laboratories doing business in the state.
As an industry, the NADL supports increased regulation and registration. In fact, in response to an NADL survey:
• 76% of members support mandatory registration requirements
• 82% support the requirement to have at least one CDT on staff
• 92% support a requirement for material and point of origin disclosure from the lab to the dentist.
ADA policy supports registration of dental laboratories in state dental practice acts, as well as material and point of origin disclosure by dental laboratories. Furthermore, ADA policy supports the value of dental technician certification as it is deemed crucial for dentists to achieve the best patient outcomes. More states should consider proactive legislation that results in the preservation of a qualified domestic dental laboratory marketplace.
In addition to state regulatory changes, the dental lab profession has experienced an increasing amount of interest from the U.S. FDA over the past two years due to the increased use of technology in the laboratory.
Traditional dental laboratories have been exempt from registering with FDA as Medical Device Manufacturers for over 30 years. The only exceptions have been those laboratories that directly import work from overseas, and labs who manufacture certain types of oral appliances (such as sleep apnea or anti-snore devices). However, due to the increasing use of digital technology in production, the FDA is beginning to view dental laboratories in a similar light to other medical device manufacturers.
In 2018, there were over 20 FDA audits of dental laboratories conducted in 14 states. There is a real possibility and likelihood that more systems and products coming out of dental laboratories in the future will fall outside the scope of the registration exemption, which would require labs to register with FDA.
Impact on the Future of Dental Group Practices & Dental Support Organizations
As the number of DSOs and group practices continue to rise, there is a growing need for qualified dental laboratory partners in the market. This is especially critical with young clinicians, many of whom practice in the DSO space. According to the ADA Health Policy Institute, nearly 18% of all dentists between the ages of 21-34 are affiliated with a DSO. A good dental laboratory partner can help support DSO initiatives through collaboration and create a strong partnership that will result in fewer remakes; quicker turnaround times and growth in services delivered.
While there are fewer labs fulfilling an increasing demand for services through increased capacity, there is also a growing reliance on the lab itself as a trusted partner and advisor to the dentist, especially with the shifting demographics in dentistry.
At the same time, the rise in acceptance of treatment options beyond single unit restorations will continue to raise the value of the laboratory and technician as a partner and resource. Again, this is especially true for younger clinicians.
The number of case consults, digital plans, digital smile designs, and other areas of support for large cases will continue to drive growth in the dentist laboratory partnership.
Consumers have more awareness of treatment options, now more than ever. To meet patient demands and expectations, dentists and management within a DSO setting need access to qualified laboratory partners who not only provide single unit restorations, but also support the clinicians and foster long-term partnerships.
Today’s dental technicians are truly dental professionals who can play an invaluable part of the DSO treatment team!