3D Printing in the Laboratory: A Primer on Regulatory Affairs

By Steven Pollack, PhD

Carbon’s journey in the dental space began in 2016 with the launch of the first M Series printer followed by materials for printing models suitable for thermoforming appliances, surgical guides, custom trays, gingiva masks and, most recently, denture bases and denture teeth. The two-year growth of Carbon’s user base has been nothing short of phenomenal. With that growth has come an awareness of the complexity of the regulatory landscape for dental materials and for our customers’ readiness to meet those requirements. 

While I’m clarifying the current regulatory landscape of 3D-printed dental devices, I have one caveat: this article is not intended as a substitute for obtaining your own legal and regulatory advice; you should always consult your advisors for advice specific to your laboratory.   

The FDA Basics

In general, the...