Boneprox reaches Class IIa certification for dental AI Umbra

Gothenburg-based Boneprox has received EU MDR Class IIa certification for Umbra, their AI-based decision support for detecting and classifying caries on dental X-rays. This makes Boneprox the first Nordic manufacturer to achieve Class IIa certification for AI-based caries detection.

Gothenburg, Sweden – 26 October 2026 – Boneprox AB has received EU MDR Class IIa certification for Umbra, its 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 notified body Ente Certificazione Macchine (NB 1282).

AI support – with the clinician in control

Umbra analyses bitewing X-rays and highlights areas that may indicate caries. The dental professional reviews the findings and remains responsible for diagnosis and treatment decisions.

The underlying AI technology has been evaluated in a peer-reviewed study published in BMC Oral Health. Researchers trained and evaluated deep-learning models using more than 13,000 bitewing X-rays annotated by dental clinicians.

The best-performing model achieved:

• 2.2 times higher mean average precision (mAP) than the highest-performing individual expert
• a significantly lower false-negative rate than four of six expert annotators

The study concluded that deep-learning models have the potential to support dental professionals in detecting caries. Further clinical validation is needed to assess how the technology performs when used in clinical practice.

Why Class IIa certification matters

Under the EU Medical Device Regulation, software that provides information used for diagnostic or therapeutic decisions is subject to risk-based classification and regulatory requirements.

For Class IIa devices such as Umbra, conformity assessment by an independent notified body is required. The assessment includes the manufacturer’s quality management system and the documentation supporting the device’s safety and performance.

“AI only belongs in the clinic if clinicians can trust it. That is why we chose the demanding route of independent assessment of our clinical evidence, quality system and the claims we make. The dentist remains in control, while Umbra provides an additional, independently assessed layer of support,” says Peder Remman, CEO and co-founder of Boneprox.

Opens the European market

The certification enables Boneprox to offer Umbra to dental clinics, partners and public dental services across the EU and EEA.

Boneprox is also developing additional areas of dental analysis that the company intends to take through the same regulatory process.

“Class IIa certification is not a one-time event. It means ongoing surveillance, post-market monitoring and full traceability. That is the standard we hold ourselves to, and the standard clinics should expect from AI used to support clinical decisions,” says Mikkel Lager, Compliance Manager at Boneprox.

A long journey from Gothenburg healthtech startup to certified medical AI

Boneprox has a long-standing connection to Sahlgrenska Science Park. The company joined Sahlgrenska Science Park’s accelerator activities in 2019 and went on to win the HealthTech Award in 2021 for its use of AI and dental X-rays to identify health risks.

Today, the company has more than 7,000 users and continues to develop clinical intelligence for dentistry from Gothenburg.

Through the CO-AX Accelerator, Sahlgrenska Science Park supports healthtech, medtech and life science companies with business development, regulatory strategy, market access, investment readiness and connections across healthcare, academia and industry.

Availability

Umbra is CE-marked as a Class IIa medical device for use across the EU/EEA. It is marketed under Nanok, Boneprox’s commercial brand for AI in dentistry, and offered directly and through selected distribution partners.

About Boneprox

Founded in 2013 and headquartered in Gothenburg, Sweden, Boneprox develops clinical intelligence for dentistry. Boneprox’s solutions have more than 7,000 users today.

The group includes Nanok, offering AI-based decision support for dental radiology, and Konekta, providing telediagnostics and digital referrals for dentistry.

Umbra is a Class IIa medical device (CE 1282).
Manufacturer: Boneprox AB, Masthamnsgatan 3, 413 29 Gothenburg, Sweden.
Certificate: ECM26MDR009.

Contact: Peder Remman, VD, Boneprox E-post: peder@boneprox.se Tel: 070-280 55 99