#USA #Copenhagen #FDA Clearance #3Shape #Dx Software

3Shape Obtains FDA 510(k) Clearance for Dx Software

COPENHAGEN, Denmark — In an exciting development for the dental community, 3Shape has received the FDA's 510(k) clearance for its innovative Dx software. Officially announced on April 28, 2026, this clearance allows the software to be launched commercially in the United States, following a thorough review completed on April 10, 2026.

A Revolutionary Tool for Dental Professionals

The 510(k) Premarket Notification paves the way for the Dx software to be utilized by qualified dentists in clinics nationwide. This software significantly aids in diagnosing critical oral health issues and assessing changes in teeth and gums among adult patients. As Jacob Paulsen, CEO of 3Shape, states, "I'm excited that we can now bring this transformative dental solution to doctors and patients across the United States."

The FDA’s endorsement reflects 3Shape’s commitment to innovation in dentistry and ensures that the software meets the stringent clinical and regulatory standards necessary for effective dental care. With the release of this tool, dental professionals will have a powerful resource for clearer communication with patients regarding their oral health and treatment options.

Features and Benefits of the Dx Software

The clearance encompasses both versions of the Dx software: Dx Plus and Dx Standard. Exclusively compatible with 3Shape TRIOS 6 scans, Dx Plus harnesses the power of AI to enhance the detection of various oral health conditions. These include:

• - Surface and proximal caries
• - Plaque accumulation
• - Tooth wear
• - Gingival recession

The more basic Dx Standard software enables dentists to manually track and quantify changes in patients' dental health.

One essential advantage of the Dx software is its capability to support routine checkups, ultimately saving time in patient visits. By utilizing Dx, dentists can display essential visualizations of oral health conditions to patients on-screen, aiding in the monitoring of these conditions over time. Furthermore, Dx Plus’s visuals transform clinical findings into comprehensible insights, fostering patient confidence and satisfaction regarding their diagnosis and proposed treatment plans.

Market Impact and Availability

With the clearance from the FDA, 3Shape's Dx software is ready for marketing and sales efforts directed toward dental professionals across the United States. Since its introduction in 2025, the software has already been deployed in various international markets, including regions in Europe, the Middle East, Africa, South America, and Canada.

As of today, dental professionals in the U.S. can purchase Dx software through their resellers or directly via 3Shape representatives. Furthermore, eligible customers are encouraged to explore trial opportunities available at webshop.3shape.com.

The finalization of this FDA approval marks a significant leap forward in dental technology, merging digital solutions with traditional practices for a modern approach to dental care and patient engagement.

For more information or assistance, dental practitioners can reach out to 3Shape's communications director, Lina Danstrup, at [email protected].