Education, entertainment served to dental laboratories at Cal-Lab Group's 2012 meeting

The 86th annual Cal-Lab meeting kicked off its day and a half of CE, networking and entertainment-much of that provided by ESPN personality and former NFL defensive lineman Mike Golic-with subjects ranging from techniques and materials, to business management and regulations.

After lunch a panel of Knight Dental Group CEO Warren Rogers, FDA regulations expert Jennifer Goldstein and DTI Director of Compliance and Regulatory Affairs Laura Sheppard, CDT, provided an overview of the status of the industry, coming regulations and preparing for an inspection by the FDA.

Rogers started things off presenting state of the industry statistics including the depressing news that last year 3 U.S. dental labs closed every day. The latest stash available show 10,482 U.S. labs of which 3,000 are one person operations. There are 1,600 NADL members, and 33,600 technicians. However, that number is down from 43,000 just two years ago.

He continued to explain that the NADL is pushing for dental lab registration at the state level along with requirements for CDTs on staff at every lab, and point of origin labeling on restorations created by labs. According to NADL studies, those proposals are supported by a wide margin the industry.

Currently there are just 9 states with requirements for dental labs to be registered, and 5 other states have pending legislation. Rogers also said he’s excited that Georgia is currently considering point of origin legislation, and more states are likely to enact registration and other requirements in the coming years.

Next Goldstein discussed how the new Sunshine Act will require labs to require dental labs to report on gifts a lab gives to dentists, and informed the crowd that implementation of the law will not happen before this summer. She also explained that the tax on medical devices will apply to all devices regulated by the FDA, which means many labs will be required to apply the 2.3% tax beginning in 2013.

However, the exact definition of what devices would be taxed remains unclear and Goldstein said she is not sure when that definition would be ironed out. Because the tax applies to medical devices when they are sold or imported, it could mean that the tax is applied on some products labs purchase or import and again when those purchases are used by the lab and resold. Keeping an eye on the development of this is going to be important for dental labs toward the end of this year.

Sheppard covered the pending Unique Device Indentified Program that will require labs to maintain records of the materials used in every restoration. The FDA will also be taking a closer look at the design and manufacture of implants and abutments.

“The FDA has a growing concern that labs don’t have adequate quality systems to confirm that labs are properly manufacturing the devices we design,” she said.

Of course, keeping up to date with regulations and documentations is not just a national issue. Dental labs need to be aware of state requirements in terms of documentation and inspections as well.

Rogers then announced that NADL will be holding a meeting with the FDA in April to talk about Good Manufacturing Practices, regulations and requirements. For dental labs it is important to start implanting a formal quality system if they have not already done so, he added.

The ensuing Q&A session featured questions about what an FDA inspection is like, and meeting attendees shared stories about FDA inspectors who have no understanding of what labs do or make. The general consensus was that it’s more about having documentation of the quality systems being used in the lab than explaining in detail to the inspector just what the lab does.

Dale Dental owner David Lesh added to the discussion that labs need to be sure they’re properly following the manufacturer instructions.

“You’re not supposed to be haphazardly mixing the chemistry set to come up with teeth,” he said.

Different FDA inspectors are different in their approach and what they want out of the inspections, Sheppard said. Her message about preparing for a possible inspection was that you have things documented and follow your documentation.

“Do what your documentation says you do,” she said before noting that the NADL has FDA compliance preparation documents available.

After Golic shared his life story and answered the crowd’s questions, DENTSPLY International CEO Christopher Clark provided a presentation on the financial state of the industry and the changing nature of the work and workforce.

He covered the market’s fall in the recent depression, spoke of the way it seems to be on the rebound and then shared data showing that digital technologies are driving the industry toward less labor intensive restorations such as all-ceramics and away from metal based restorations. Other growth areas include removables, implants and custom abutments.

DENTSPLY believes strongly in this growth area and showed this with the purchase of Astra Tech and that company’s Atlantis custom abutment products. The company’s full implant portfolio is being combined under the newly created DENTSPLY Implants brand.

Automation is another key for labs. Labs are succeeding by automating everything they can. This is changing the nature of the skill sets required to be a dental technician. With these efficiencies, labs are able to improve both productivity and profitability. Labs are still the experts in the industry in terms of both materials and technology and can bring that value to their dentists.

Following the presentations, it was time for the real highlight of the Cal-Lab meeting, the exhibition and reception. With hors d' oeuvres in abundance and companies displaying their latest products and services, the social side of the industry was on display. This is where the community of dental labs really comes out, as connections were solidified, old friends visited and new ones made.