Intended use
What Faurenis is for, and what it is not.
The intended use we design and sell against, and its regulatory status as of the date below.
Intended use
Faurenis is an AI-assisted clinical documentation platform for dental clinics. It helps dentists create accurate clinical records faster by drafting SOAP notes, periodontal charts and session summaries, all of which are reviewed and approved by the treating dentist before they become part of the official patient record. The AI assists; the clinician decides.
Status as of 6 August 2026
What Faurenis is not
Not a diagnostic system
It does not diagnose disease or detect pathology. It helps document the findings the clinician makes.
Not a treatment decision-maker
It drafts recommendations for the clinician to review. It does not recommend treatment without clinician review.
Not a prescriber
It does not prescribe medication.
Not a replacement for clinical judgment
It supports clinical documentation and workflow. The clinical decision stays with the dentist.
No CE mark, and no clinical study yet
Faurenis holds no CE mark and no FDA clearance, and has not been through a formal clinical study. This page will say so when that changes.
Regulatory status
EU Medical Device Regulation (MDR 2017/745)
Whether Faurenis qualifies as a medical device depends on its intended purpose statement and on how the competent authority interprets it; in Croatia, that is HALMED. The question has not been decided, and it is under review with legal and regulatory counsel. Faurenis is not CE marked and is not registered as a medical device.
EU AI Act (Regulation 2024/1689)
For software like Faurenis, the AI Act's high-risk route runs through the MDR: under Article 6(1), an AI system is high-risk when it is, or is part of, a medical device that needs a third-party conformity assessment. Its classification therefore follows the MDR question, and is under the same review. Transparency obligations can apply either way.
AI drafts enter a clinician-review lifecycle, and no AI output becomes part of the official record without a dentist's acceptance. See each safeguard and what enforces it.
When any of this changes (a classification decision, a CE mark, a notified body), this page changes first, with the new date.
Regulatory questions
Ask us about the classification work.
Your DPO or regulatory lead can get the detail behind this page from us directly.