11 November 2026

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First-ever Dental Dedicated MRI Cleared by FDA for Advanced Soft‑Tissue Diagnostics

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MAGNETOM Free.Max Dental Edition was developed jointly by Dentsply Sirona, Siemens Healthineers, and leading scientists in Europe and the United States.

Dentsply Sirona and Siemens Healthineers have collaborated on the first‑ever dental‑dedicated MRI 1 (ddMRI) system–MAGNETOM Free.Max Dental Edition, which recently received FDA clearance in the United States. This milestone follows the completion of a clinical trial 2 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.

The 2 companies shared 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 minutes 3 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,” stated 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,” Dan Scavilla, President & CEO of Dentsply Sirona, added.

“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,” Andreas Schneck, head of Magnetic Resonance at Siemens Healthineers, said in the press release.

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

Source: https://dentalcetoday.com/