3Shape Receives FDA 510(k) Clearance for 3Shape Dx Software
Copenhagen, April 27. 2026 - 3Shape today announced that the U.S. Food and Drug Administration (FDA) has granted FDA clearance for its Dx Software following a review completed on April 10. 2026.
The 510(k) Premarket Notification allows Dx (R1) software to be commercially available in the United States for use by qualified dental professionals in dental clinics to aid in the diagnosis of key oral health conditions and the assessment of changes in teeth and gingiva in adult patients.
“I’m excited that we can now bring this transformative dental solution to doctors and