NADL Heightens Industry Awareness

If one were to ask almost any laboratory owner what one of their biggest challenges is, the answer would likely revolve around finding, and keeping, good employees.  Even laboratories that are open to hiring those new to the industry and training are still struggling to just find people. This employment gap, however, is not unique…

FDA Inspections Are Not All the Same – Two Recent Cases

In the past decade, the FDA has increased the number of device manufacturing establishment inspections. Pre-COVID, in 2017, the FDA conducted 2,952 inspections of medical device firms, representing a 46 percent increase compared to a decade earlier. FDA also increased foreign inspections 243 percent. In 2018, FDA regional field offices launched inspections of dental laboratories…

Collaboration Equals Better Case Acceptance

Collaboration between dental laboratories and dental offices plays a significant role in the future of the dental industry. Advancement in digital tools has increased collaborative abilities via sophisticated dental technology and virtual communication innovations. There is no guarantee that patients will accept a treatment plan. Patients’ reluctance to accept treatment is primarily due to their…

FDA QSR UPDATE – ISO 13485 Alligned QMSR Final Rule Getting Closer

By Eric Thorn, Esq Beginning back in the spring of 2018, FDA announced its intent to adopt rules to replace the current quality system regulations (QSR) found in 21 CFR Part 820 with rules more aligned with International Organization for Standardization (“ISO”) standard ISO 13485:2016 (ISO 13485). This year, on February 23, 2022, FDA published…

Digital Workflows: Provide Benefits to Accuracy, Consistency, and Efficiency

Over the last decade, the implementation and optimization of digital workflows have played a vital role in our business. Although we still have several traditional, “analog” components to our workflow, digital integration has delivered a remarkable level of accuracy, consistency, and efficiency across thousands of projects. As a lab that strives for continuous innovation, we…

Celebrating Skill, Reliability, and Adaptability: Dental Technician and CDT Appreciation Month

NBC, NADL, and FDLT are extremely pleased to dedicate the month of June to the appreciation of dental technicians and Certified Dental Technicians (CDTs). Dental technicians and CDTs develop specialized skills in order to provide care to patients in need. The reliability of that care is fortified by dedication to standards of excellence and continuing…

Mapping a New Course to Shade Determination

Introduction Although many aspects of dentistry have seen massive improvements in technology, process, and efficiency, shade communication and determination have been largely unchanged. The introduction of Mobile Dental Photography has not only expedited a technical jump, but has also opened the door to stark process improvements. Accelerated by a pandemic and the near extinction of…

FDA 510(k) Clearance – An Overview

By Eric Thorn, Esq. Well to start off with, no a 510(k) is not some type of retirement plan, that’s a 401(k).  Section 510(k) is a section of the Food, Drug and Cosmetic Act (FD&C Act) that requires device manufacturers to provide the Food and Drug Administration (FDA) with at least 90-day advance notice of…