According to data from the U.S. Department of Labor, Bureau of Labor Statistics, there are more than7,000 dental laboratories in the United States. Now regulated by the U.S. Food and Drug Administration, they must each adhere to strict and often complicated rules—including the government’s new 21 CFR 820 guidance.
“Dental lab owners have told me that they are worried how new guidance policies will negatively affect their CAD/CAM department’s business,” stated Tim Torbenson, the company’s president. “They also have concerns regarding their ability to document internal processes in their laboratories to comply with and satisfy the FDA oversight.”
As the VP of Regulatory Affairs and Quality Assurance for a dental implant manufacturer, Torbenson has monitored the FDA’s push to require dental laboratories of all sizes into incorporating a Quality Management System (QMS) through 21 CFR 820. While most dental lab owners welcome enhanced safety measures, the rules present them with a variety of challenges and unknowns.
“The FDA’s 21 CFR 820 is completely foreign to the dental laboratory industry and will require an experienced regulatory team with knowledge of dental laboratory CAD/CAM workflow to help guide them through this process,” stated Torbenson. “Presently there are no other regulatory consulting firms that are 100% dedicated specifically to the CAD/CAM dental laboratory.”
Previously, dental laboratories were exempt from FDA oversight due to the fact that their procedures and processes were considered more of a craft. In the past, technicians used the lost wax casting technique to create custom full cast crowns or copings and brushes to layer porcelain. In doing so, this created patient specific shaded porcelain crowns. Because the dental laboratory industry has now moved to a computer-based workflow (CAD/CAM), the FDA reclassified the process as Contract Manufacturing of Class II Medical Devices.
“Since the 21 CFR 820 guidance is largely intended for medical device manufacturers, many of its requirements do not apply to the operations within a dental laboratory,” explained Torbenson. “As a result, evo820 has assembled a QMS that is specifically applicable to the operations and processes that do exist in the CAD/CAM dental laboratory. This customized QMS will satisfy the FDA requirements while preventing labs from incorrectly documenting processes or unnecessarily documenting procedures.”
To further simplify the process and assist labs with compliance, evo820 provides dental laboratories with access to their very own QMS on the company’s website. There, they can retrieve and download documents or forms from a cloud server to use in the maintenance of their quality manual. evo820 also monitors the activity of every lab’s QMS and provides guidance in maintaining compliance through email alerts that come from evo820 staff.
“Our goal is to do what we do so well that our customers will want to share with their peers,” stressed Torbenson. “We understand their concerns and apprehension with the process of incorporating a QMS into their operations and consider these issues when interacting with them. We provide comfort and confidence that their business will move to compliance with the FDA new guidance.”
To learn more about the company and services available to dental laboratories nationwide, click here.
Based in Carson City, Nevada, evo820 was founded by dental lab professionals to help CAD/CAM dental laboratories nationwide evolve into entities that are FDA 21 CFR 820 compliant. Through the company’s innovative platform, dental labs are able to satisfy the FDA’s requirements by following a practical and affordable implementation of a customized Quality Management System.