3Shape Achieves FDA Clearance for Groundbreaking Dx Software in Dentistry

3Shape Launches FDA-Cleared Dx Software for Dental Professionals

COPENHAGEN, Denmark – 3Shape, a leading provider of dental technology, has proudly announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its advanced Dx software as of April 10, 2026. This significant milestone allows for the commercial availability of Dx software in the United States, specifically designed for qualified dental professionals in clinics. It aids in the diagnosis of critical oral health conditions and assessments of dental changes in adult patients.

In an official statement, 3Shape CEO Jacob Paulsen expressed enthusiasm for bringing this transformative dental solution to both practitioners and patients throughout the United States. He emphasized that receiving FDA 510(k) clearance for the Dx software reflects their strong commitment to responsible innovation while ensuring that their digital solutions adhere to the highest clinical and regulatory standards. The functionality of the Dx software enables dental professionals to facilitate clearer communication with patients regarding their oral health and specific treatment needs.

3Shape offers two different versions of the Dx software: Dx Plus and Dx Standard. The Dx Plus version is particularly noteworthy; it is an AI-assisted software designed to detect various oral health issues such as surface and proximal caries, plaque build-up, tooth wear, and gingival recession. Moreover, its compatibility is exclusive to 3Shape TRIOS 6 scans, enhancing its specialization in high-precision diagnostics. The Dx Standard version serves to engage patients actively by allowing clinicians to manually track and quantify changes in their dental conditions, and it is compatible with all TRIOS models with the exception of TRIOS Core.

One remarkable aspect of the Dx software is its ability to support routine checkups efficiently, significantly saving time when preparing for patient visits. Dentists using this innovative technology can visually represent essential oral health conditions through on-screen illustrations, facilitating a deeper understanding for patients. With Dx Plus, clinical findings are transformed into clear and intuitive visuals, designed to build trust between clinicians and patients, thereby instilling confidence in the recommended treatment plans.

With this FDA clearance, 3Shape is now positioned to market and sell the Dx software effectively to dental professionals operating in the U.S. Since its launch in 2025, the software has garnered positive traction in numerous international markets, including regions such as Europe, the Middle East, Africa, South America, and Canada.

As of today, 3Shape's Dx software is officially accessible in the United States. Interested dental professionals can reach out to their resellers or connect with a 3Shape representative for additional purchase information. Furthermore, eligible customers can visit the official webshop at webshop.3shape.com to initiate a trial of the innovative software.

In a fairly stagnant field, the arrival of the Dx software marks a groundbreaking shift, promising improved diagnostic capabilities and enhanced patient-clinician interactions in dental care. As the technology continues to evolve, it becomes apparent that 3Shape is at the forefront, leading the charge in innovative dental solutions. The advancement of telemedicine and digital diagnostics is not just a trend but a critical necessity in today's ever-evolving health landscape, fortifying 3Shape's commitment to enhancing oral health through advanced technology and responsible innovation.

For media inquiries, please reach out to:
Lina Danstrup
Director and Head of Corporate Communications
[email protected]

Stay tuned for further updates as 3Shape continues to make waves in the dental technology industry, setting benchmarks for quality, precision, and patient care.