Dentsply Sirona and Siemens Healthineers have received FDA clearance for the MAGNETOM Free.Max Dental Edition — the first MRI system dedicated entirely to dental diagnostics. The announcement, made on March 9, 2026, follows a multi-site clinical trial validating the system's effectiveness across endodontics, periodontics, TMJ assessment, orthodontics, and oral surgery planning.
A New Era in Dental Imaging
The dental-dedicated MRI (ddMRI) represents a fundamental shift in diagnostic imaging for dentistry. For decades, dental professionals have relied on X-ray-based technologies — periapical radiographs, panoramic images, and cone-beam computed tomography (CBCT). While these modalities excel at visualizing hard tissue structures like bone and teeth, they have limited ability to image soft tissues and expose patients to ionizing radiation.
MRI changes this equation entirely. Using magnetic fields rather than X-rays, the MAGNETOM Free.Max Dental Edition produces detailed images of pulp tissue, inflammation, nerve pathways, and soft tissue masses without any radiation dose. This is particularly significant for patients requiring repeated imaging, pediatric patients, and pregnant women where radiation exposure must be minimized.
How the System Works
The MAGNETOM Free.Max Dental Edition uses a specialized dental coil designed to fit around the lower face, paired with software optimized for oral and maxillofacial structures. Unlike full-body MRI systems used in hospitals, this dental-specific configuration creates a focused field of view centered on the teeth, jaws, and surrounding tissue — it does not image the brain, which simplifies interpretation and reduces scan time.
Average workflow time is under 20 minutes per scan, which is comparable to a comprehensive CBCT examination. The system operates at a lower magnetic field strength than traditional medical MRI units, which reduces equipment costs and facility requirements while still producing clinically diagnostic images.
Clinical Trial Results
The multi-center clinical trial demonstrated several capabilities that cannot be achieved with any X-ray-based modality. The system can reliably differentiate between active pulp inflammation and necrotic or scarred tissue — a distinction critical for endodontic treatment planning that currently relies on subjective thermal and electrical pulp testing. It enables visualization of the inferior alveolar nerve pathway with soft tissue contrast, providing safer extraction and implant placement planning.
The trial also showed promising results in TMJ diagnostics, where soft tissue visualization of the articular disc is essential but previously required referral to a medical imaging center. Orthodontic applications include assessment of tooth eruption pathways and root resorption patterns.
Market Impact and Pricing
For Dentsply Sirona, the ddMRI launch represents a strategic expansion beyond its traditional X-ray and CBCT portfolio, potentially opening an entirely new equipment category in dentistry. The partnership with Siemens Healthineers brings decades of medical-grade MRI expertise into the dental space for the first time at a clinically practical scale.
The system targets multi-specialty practices, university dental schools, hospital-based dental departments, and large group practices. While official pricing has not been disclosed, industry analysts estimate the initial cost will be significantly higher than premium CBCT systems (which typically range from EUR 80,000-150,000). However, the total diagnostic value proposition includes eliminating referrals to medical imaging centers, which can cost EUR 300-500 per scan.
Training and Availability
Clinicians interested in incorporating ddMRI into their practice can participate in an advanced, hands-on training program launching at the University of Minnesota in April 2026. Dentsply Sirona has established partnerships with several European dental schools for additional training sites.
The system is initially available in the United States. European regulatory submissions are underway, with CE marking expected in the second half of 2026. Dentsply Sirona has indicated that pricing and distribution partnerships for European markets, including CEE, will be announced following regulatory clearance.
Relevance for CEE
For CEE dental professionals, ddMRI could have the most immediate impact in two areas. First, implantology centers performing complex cases near the inferior alveolar nerve or maxillary sinus could benefit from superior soft tissue visualization for pre-surgical planning. Second, university dental departments could use ddMRI for research and advanced diagnostics without the radiation burden associated with CBCT research protocols.
The technology is unlikely to replace CBCT in the near term — CBCT remains superior for hard tissue visualization and is significantly less expensive. Rather, ddMRI will likely emerge as a complementary modality for specific clinical indications where soft tissue information is critical.
FAQ
What is dental-dedicated MRI? A magnetic resonance imaging system designed specifically for oral and dental structures, using a specialized coil and software to image teeth, gums, pulp tissue, and surrounding structures without ionizing radiation. It complements rather than replaces CBCT.
How does ddMRI differ from CBCT? CBCT uses X-rays and excels at hard tissue visualization (bone, teeth, implant planning). MRI provides superior soft tissue imaging (pulp vitality, inflammation, nerve pathways, TMJ disc) without radiation exposure. They serve different clinical indications.
When will the system be available in Europe? Dentsply Sirona has indicated European regulatory submissions are underway, with CE marking expected in the second half of 2026. Distribution and pricing for European markets will be announced following regulatory clearance.
How much does it cost? Official pricing has not been disclosed. Industry estimates place it significantly above premium CBCT systems, targeting multi-specialty and institutional settings initially.
Source: Dentsply Sirona / GlobeNewsWire