First-ever Dental Dedicated MRI Validated in Clinical Trial and Cleared by FDA for Advanced Soft-Tissue Diagnostics
Dentsply Sirona and Siemens Healthineers are pleased to announce that the first-ever dental-dedicated MRI1 (ddMRI) system – MAGNETOM Free.Max Dental Edition – has received FDA clearance in the United States. This milestone follows the completion of a clinical trial2 validating the system's significant potential across multiple dental specialties. The trial highlighted this first-of-its-kind technology's applicability in endodontics, periodontics, TMJ, tooth extraction, and orthodontics, offering non-ionizing imaging capabilities that can enhance diagnosis and treatment planning.
CHARLOTTE, N.C., March 09, 2026 (GLOBE NEWSWIRE) -- Dentsply Sirona and Siemens Healthineers are pleased to share key findings from the clinical trial for validation of their dental-dedicated MRI system. In addition to confirming its significant potential across multiple dental specialties, the trial also underscored the ddMRI system's specialized features designed to meet the unique needs of dental professionals. Among these features is a dental-specific field of view, enabled by a dedicated dental coil and specialized software that focuses exclusively on dental structures, ensuring no brain tissue is visible and allowing for accurate imaging of dental structures. Additionally, the system's ability to streamline patient preparation and maintain an average workflow time of under 20 minutes3 makes it a highly efficient tool for clinical use.
Clinical highlights from the trial demonstrated MAGNETOM Free.Max Dental Edition's ability to differentiate active inflammation from healthy and scar tissue, enable non-invasive assessment of tooth pulp vitality to support chairside testing and observations and enables the visualization of teeth and their position in relation to neighboring teeth as well as the nerves.
"MAGNETOM Free.Max Dental Edition represents a significant advancement in dental imaging, providing excellent insights into dental structures that were not readily visible in other imaging modalities, without the risks associated with ionizing radiation. The ability to observe the same region of interest employing different ddMRI imaging sequences provides significantly more information regarding the pathological processes in hard and soft tissues which results in a more accurate understanding of the lesion. This capacity to see the clarity of the soft tissue detail produced by ddMRI has clear potential to enhance diagnostic confidence in areas where current modalities have limitations," said Prof. Don Tyndall, DDS, MSPH, PhD, FICD, FACD; Diplomate ABOMR, Professor of Diagnostic Sciences at University of North Carolina, who reviewed the clinical trial findings and collaborated in the FDA clearance process.
Dental-dedicated MRI: excellent complement to existing imaging solutions
As an ionizing radiation-free modality with advanced soft tissue contrast, ddMRI complements intraoral, panoramic, and CBCT imaging by addressing diagnostic questions where soft tissue characterization is critical.
MAGNETOM Free.Max Dental Edition, the first-of-its-kind dental-dedicated MRI, was developed jointly by Dentsply Sirona, Siemens Healthineers, and leading scientists in Europe and the United States. Specifically designed to enhance dentomaxillofacial diagnostics, ddMRI is primarily intended for hospitals, large clinics, and universities, and offers advanced soft tissue contrast through ionizing radiation-free imaging.
"This innovation is a powerful addition to our imaging portfolio, which includes Axeos, Orthophos SL, and Heliodent Plus, among others. We're proud to have contributed to developing the industry's first dental dedicated MRI and the advancement of diagnostic capabilities in the field," observed Dan Scavilla, President & CEO of Dentsply Sirona.
"We are dedicated to expanding the clinical impact and reach of MRI. We are excited to see the potential of ddMRI being validated through clinical trials, which will pave the way for a new clinical field that will benefit dental practitioners and patients alike," said Andreas Schneck, head of Magnetic Resonance at Siemens Healthineers.
Advanced Clinical Training Opportunity
Clinicians interested in incorporating ddMRI into their practice can participate in an advanced, hands‑on training program taking place in April 2026 at the University of Minnesota. This two‑day course covers ddMRI imaging protocols, recommended clinical procedures, essential MR facility and patient safety guidelines, hands‑on image acquisition, and practical interpretation sessions featuring TMJ and dental cases.
For more details, please visit Introduction to Dental MRI: A Hands‑on Program | School of Dentistry.
Learn more at the upcoming American Dental Education Association (ADEA) Annual Session
Visit the Dentsply Sirona booth at the American Dental Education Association (ADEA 2026) Annual Session, taking place March 21–24 in Montréal, Canada, and learn more about the first dental-dedicated magnetic resonance imaging (ddMRI) system.
Learn more at www.dentsplysirona.com/ddmri
Registered brands, trade names and logos are used. Even in particular cases, when they appear without a TM or ®, all corresponding legal rules and provisions apply. All rights are retained by Dentsply Sirona. Clinicians may have been compensated for use of their experiences and testimonials.
About Dentsply Sirona
Dentsply Sirona is the world's largest diversified manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world-class brands. Dentsply Sirona's innovative products provide high-quality, effective and connected solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona is headquartered in Charlotte, North Carolina. The Company's shares are listed in the United States on Nasdaq under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.
Contact Information:
Dentsply Sirona Press Contact:
Marion Par-Weixlberger
Vice President, Public Relations, Corporate Communications & Brand
[email protected] | www.dentsplysirona.com
Siemens Healthineers Press Contact:
Stefanie Haug | Magnetic Resonance Imaging, Computed Tomography and X-ray
+49 173 6358240 | [email protected]
1 The product mentioned here is not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed.
2 Clinical Evaluation Report, MAGNETOM Free.Max Dental Edition, 2025. Copyright@Siemens Healthineers. Data on file.
3 Greiser et al. (2023): Dental-dedicated MRI, a novel approach for dentomaxillofacial diagnostic imaging: technical specifications and feasibility, in: Dentomaxillofacial Radiology, 2023, 00, 1-12
