Boneprox receives EU MDR Class IIa certification for its dental AI – first in the Nordics

Boneprox’s AI-based decision support has been certified as a Class IIa medical device following independent assessment, making Boneprox the first Nordic manufacturer to achieve this.

Gothenburg, Sweden - Boneprox AB has received EU MDR Class IIa certification for Umbra (certificate ECM26MDR009), the company’s AI-based decision support for detecting and classifying caries on bitewing X-rays. The certification follows an independent assessment of Boneprox’s quality management system, technical documentation and clinical evidence by the notified body Ente Certificazione Macchine (NB 1282).

Built to be trusted

The decision support helps licensed dental professionals detect and classify caries on X-rays. It highlights areas that may indicate caries, and the clinician reviews every finding and makes every decision.

In a peer-reviewed clinical study published in BMC Oral Health, the solution showed:

• 2.2x higher detection performance (mAP) than the top individual expert

• a 60% lower missed-lesion rate (mFNR) than the average expert annotator

In Boneprox’s internal performance testing, results are delivered with a median analysis time of under 0.2 seconds.

Why certification matters

Under the EU Medical Device Regulation, software that supports diagnostic decisions must be at least Class IIa, which requires independent review by a notified body. For clinics, this provides assurance that a tool’s clinical performance, safety and quality have been verified externally. The certification enables Boneprox to offer the solution to clinics, partners and public dental services across the EU/EEA. It also provides a foundation for developing Boneprox’s clinical intelligence further. New analysis areas are being developed to undergo the same independent regulatory process.

“We have been building Boneprox from inside the clinic for 13 years, and one thing has remained constant: clinical intelligence only belongs in the clinic if clinicians can trust it. That is why we chose the demanding route, with independent assessment of our clinical evidence, our quality system and every claim we make. Dentists should never have to wonder whether the tool in front of them is properly validated. The clinician stays in control, and our decision support adds a consistent, independently certified layer of support to every bitewing review.” Peder Remman, CEO and Co-founder, Boneprox

“Certification is not a one-time event. Class IIa means ongoing surveillance by our notified body, continuous post-market monitoring and full traceability. That is the standard we hold ourselves to, and the standard clinics should expect from anyone offering AI for clinical decisions.” Mikkel Lager, Compliance Manager, Boneprox.

Availability

The solution is CE-marked for use across the EU/EEA. It is marketed under the Nanok brand, Boneprox’s commercial channel for AI in dentistry, and offered directly and through selected distribution partners.

About Boneprox

Founded in 2013 and headquartered in Gothenburg, Sweden, Boneprox builds clinical intelligence for dentistry. Boneprox’s solutions have more than 7,000 users today. Boneprox includes Nanok (AI-based decision support for dental radiology) and Konekta (telediagnostics and digital referrals for dentistry).

Umbra is a Class IIa medical device (CE 1282). Manufacturer: Boneprox AB, Masthamnsgatan 3, 413 29 Gothenburg, Sweden.

Media contact:  Peder Remman, CEO, Boneprox

Email: peder@boneprox.se

Phone: +46 70 280 55 99