3Shape announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its Dx software following a review completed on April 10, 2026. According to the company, the clearance allows Dx (R1) software to be commercially available in the United States for use by qualified dental professionals in clinics to aid in diagnosing oral health conditions and assessing changes in teeth and gingiva in adult patients.
“I’m excited that we can now bring this transformative dental solution to doctors and patients across the United States,” says Jacob Paulsen, CEO of 3Shape. “Receiving FDA 510(k) clearance for Dx underscores our commitment to responsible innovation and to delivering digital solutions that meet the highest clinical and regulatory standards. With Dx software, dental professionals gain a powerful new way to communicate more clearly with patients about their oral health and treatment needs.”
According to the company, the clearance applies to both versions of the software, Dx Plus and Dx Standard. Dx Plus is designed as an AI-assistive tool that works exclusively with 3Shape TRIOS 6 scans and aids in detecting conditions such as surface and proximal caries, plaque, tooth wear, and gingival recession. Dx Standard allows dentists to manually track and quantify changes in dentition and is compatible with all 3Shape TRIOS models except TRIOS Core.
The software supports routine checkups and may reduce preparation time before patient visits, according to the company. Dentists can use the platform to visualize oral health conditions chairside and monitor them over time. According to the company, Dx Plus visualizations present clinical findings in a format intended to support patient understanding and discussions about treatment.
The FDA clearance enables the company to market and sell Dx software to dental professionals in the United States. According to the company, the software has been in use since 2025 in international markets including Europe, the Middle East, Africa, South America, and Canada.
3Shape stated that Dx software is now available in the U.S., and more information is available at webshop.3shape.com.
