IFU

1. Product identification and regulatory information

2. Intended purpose

Dentio is medical device software intended to support licensed dentists and dental hygienists with the AI-assisted preparation of clinical documentation.

The software receives audio recordings, free text, or PDF files from dental care encounters and converts them into a draft of clinical documentation. The clinician reviews, edits, and approves or rejects the draft before it is transferred to the patient record system. The purpose is to improve the quality, completeness, and consistency of clinical documentation and to reduce the documentation burden for clinicians.

All generated output is a draft that is deleted unless it is reviewed, edited, approved, and exported by a licensed dentist or dental hygienist. The output includes drafts of clinical record documentation, referrals, referral responses, dental status records, and support for periodontal recording, all within Dentio’s controlled workflow. Dentio does not replace professional clinical judgement, does not provide diagnostic or therapeutic decision support, and does not constitute a basis for clinical action.

The current version supports documentation preparation in Swedish, Norwegian, Danish, and Finnish in Sweden, Norway, Denmark, and Finland. Use outside these languages or markets is outside the intended purpose.

Reminders (administrative support function). Dentio also includes an administrative reminder function. The function is intended to support the user’s own work tasks and is outside Dentio’s medical documentation function. Reminders are not clinical record entries, clinical decision support, treatment recommendations, medication instructions, clinical alerts, or time-critical follow-up systems.

3. Intended users, patient population, and use environment

Intended users are dentists and dental hygienists who are licensed to practise in the country where they work and are authorised to manage clinical documentation. The user must have sufficient command of the selected documentation language to review, edit, and approve documentation in that language; have completed Dentio onboarding or equivalent training approved by their organisation before using the system independently; and be able to identify when AI-generated content is incomplete, incorrect, or inappropriate for the clinical situation.

Patients, members of the public, administrative staff without relevant training, dental assistants acting independently as final approvers, and external parties who are not part of Dentio’s controlled workflow are not intended users.

Patient population: Patients receiving dental care in Norway, Sweden, Denmark, or Finland, including adults, children, and older people, in general and specialist dental care. No patient subgroups are excluded on the basis of age, medical history, or dental status, provided that use remains limited to documentation support under clinician review and approval.

Use environment: Professional dental care environments (public and private clinics), indoors, with reasonable conditions for audio recording and the ability to maintain the review and approval process before documentation is used.

4. Indication and expected clinical benefits

Indication: AI-assisted drafting of clinical dental documentation and related record-keeping in Swedish, Norwegian, Danish, or Finnish during or immediately after a dental visit.

When Dentio is used in accordance with its intended purpose and all generated content is reviewed by an authorised user, the expected benefits are:

• improved completeness and consistency of clinical documentation,
• a reduced risk of documentation-related omissions in routine workflows,
• support for accurate and up-to-date dental documentation,
• a reduced documentation burden for clinicians,
• support for structured workflows for clinical notes, referrals, referral responses, odontograms/status records, and periodontal charting.

The benefits are indirect and depend on proper user review and approval. Dentio does not create a clinical benefit by replacing clinical judgement.

5. Performance

Dentio’s performance has been verified for the approved release baseline. Actual performance depends on audio quality, the correct patient context, the accuracy of the user’s source material, and the user’s mandatory review.

Performance may be lower where there is poor audio quality, background noise, overlapping speech, an incorrectly selected microphone, unclear speech, dialect variation, mixed languages, incomplete source material, or use outside the approved conditions.

For free-text and PDF-based workflows, quality primarily depends on the user providing correct and complete source material and on text being extracted from documents correctly. The user must always compare and review the result before approval.

6. Contraindications and unintended use

No product-specific clinical contraindications have been identified when Dentio is used within its intended documentation-support purpose and subject to mandatory user review.

Dentio must not be used:

• where a licensed dentist or dental hygienist cannot review and approve the draft before clinical use,
• as decision support for diagnosis, treatment choices, triage, risk assessment, or emergency care,
• as the primary or sole basis for clinical decisions,
• to determine the need for a referral, referral urgency, recipient, referral route, or whether it is sent,
• to interpret radiographs, physiological measurements, or other diagnostic data,
• to provide prompts, reminders, suggestions about missing information, live questions, or other instructions intended to influence clinical action,
• in emergency situations where review and approval cannot realistically be maintained,
• to sign, finalise, or enter clinical record text automatically without active clinician approval,
• for standalone remote or teledentistry care beyond the approved release.

Do not use Dentio for patient messages or for TLV-defined administrative procedure-code support in the current MDR-regulated configuration. Such workflows are not part of Dentio’s intended medical-device purpose.

7. Warnings

• Clinician review is mandatory. All AI-generated content must be read, checked, corrected where necessary, and explicitly approved by a qualified user before it is saved, entered into the clinical record, copied, exported, transferred, or used.
• Do not rely solely on AI. AI-generated text may be well written and plausible yet still contain errors, omissions, fabricated content, incorrect structuring, or incorrect speaker attribution.
• Do not use Dentio as clinical decision support. Dentio must not be used for diagnosis, treatment choices, triage, risk assessment, clinical alerts, radiograph interpretation, or automated medical decision-making.
• Always verify the patient and visit. Check that the correct patient and visit are selected before recording, review, approval, and transfer. Stop the workflow immediately if the wrong patient or visit is suspected.
• Language and audio limitations may affect safe use. Dentio supports documentation drafts in Swedish, Norwegian, Danish, and Finnish. If the consultation or source material uses a language not supported by the current release, or contains mixed languages, unclear speech, a strong dialect, overlapping speech, or poor-quality audio, the draft must be reviewed with extra care or replaced with manual documentation.
• Pay attention to uncertainty markers. Content marked with (?) indicates low AI confidence and requires specific manual verification before approval or transfer.
• Take particular care when verifying referrals and referral responses. Check the recipient, clinical question, patient context, and that no unsupported or incomplete content has been added. Dentio does not determine the need for a referral, urgency, recipient, referral route, or whether it is sent.
• Protect patient data. Use individual accounts, do not share login details, lock the screen when away, and use only approved devices, browsers, and network routes. Report suspected unauthorised access without delay.

8. Precautions

• Use Dentio only after onboarding or organisation-approved training and only within the intended use environment in Norway, Sweden, Denmark, or Finland.
• Check the patient, visit, microphone, browser, and network connection before recording starts and whenever a paused workflow is resumed.
• If reliable recording, processing, editing, or review cannot be maintained, the user must stop the workflow and use the clinic’s fallback procedure for manual documentation.
• In free-text and PDF-based workflows, the user must verify that the source material is correct, complete, and relevant to the current visit before approving the draft.
• Review each document type separately. Approval of a clinical note does not mean that a referral, referral response, odontogram, or periodontal documentation has been reviewed.
• After copying, exporting, or transferring content, the user must check that the text is displayed correctly in the receiving clinical record system or workflow before the documentation is considered complete.
• If editing controls, the undo function, document switching, or transfer behave unexpectedly, the user must stop the workflow, verify the context, and use the fallback procedure if necessary.
• Handle, review, and transfer relevant drafts before local or organisational retention periods expire.

9. Residual risks

All identified risks have been reduced to an acceptable level in accordance with Dentio’s risk management process and ISO 14971:2019. Residual risks include, but are not limited to:

• AI-generated content containing errors, omissions, or fabricated content,
• incorrect speaker attribution,
• documentation linked to the wrong patient or visit due to inadequate context verification,
• the wrong recipient or incomplete content in a referral or referral response,
• incorrect or incomplete interpretation of PDF or free-text source material,
• delayed or interrupted documentation during a service disruption,
• reduced performance under non-validated audio, language, or source-material conditions,
• possible exposure of patient data due to insecure account management or shared devices.

These risks are primarily managed through mandatory clinician review, clear workflows, user training, local IT security procedures, and the ability to return to manual documentation. No adverse events or product defects are known at the date of issue.

10. Technical requirements

Dentio is a web-based cloud service. No user installation is required.

• Device: desktop or laptop computer. Mobile phones, tablets, remote desktops, and virtualised environments are outside the approved configuration.
• Operating system: Windows (x64), macOS (Intel or Apple Silicon), or Linux (x64), in a version that still receives security updates from the vendor.
• Browser: the current version or one of the two latest major versions of Google Chrome, Microsoft Edge (Chromium), Mozilla Firefox, or Apple Safari.
• Display: minimum resolution of 1440 × 900.
• Microphone: a functioning built-in or external microphone for audio-based workflows.
• Network: a stable internet connection with an upload speed of at least 1 Mbps.
• Permissions: JavaScript, secure cookies, and microphone permission enabled in the browser.

11. Using Dentio

1. Open app.dentio.com in a supported browser and sign in using Mobile BankID or valid personal login credentials.
2. Select the correct patient and visit. Verify the selection before starting the recording.
3. Confirm that microphone access is allowed and that the correct device is selected.
4. Start recording or another approved input method and conduct the consultation.
5. End the session and wait for processing to finish.
6. Review the generated drafts in full, including all uncertainty markers and each active document type.
7. Make any necessary corrections manually, through the chat tab, or by using “Tell the AI what to rewrite”.
8. Verify the patient and visit one final time and approve only content that is correct and complete.
9. Transfer or copy the content to the clinical record system and confirm that it is displayed correctly.

The pause function must only be used for temporary interruptions. When resuming, check the patient, session, and microphone again.

12. Malfunction and fallback procedure

In the event of an error, service disruption, or uncertain operation, the user must stop the workflow, switch to the clinic’s manual documentation procedure, and contact Dentio support if necessary. Avoid repeating a transfer or upload before confirming whether the earlier action succeeded, to prevent duplicate or incomplete clinical record entries.

13. Decommissioning and maintenance

When use ends, the clinic must check that relevant documentation has been reviewed and handled, sign out, lock or sign out of shared workstations, and remove any local copies in accordance with the clinic’s data protection procedures. To close an account, request data erasure under the GDPR, or terminate the service, contact [email protected].

No periodic user maintenance is required beyond keeping the browser and device up to date. Dentio updates the system through controlled releases. Safety-relevant changes and updated IFUs are communicated before new or changed workflows are put into clinical use.

14. Reporting serious incidents

Users and healthcare professionals must promptly report suspected serious incidents, significant malfunctions, recurring errors that may affect safe use, and suspected cybersecurity or data-integrity issues to Dentio. For a serious incident, also follow applicable national reporting requirements and report to the competent authority for the country where the user and/or patient is established.

• To the manufacturer: [email protected].
• In Sweden: the Swedish Medical Products Agency (Läkemedelsverket).
• In Norway: the Norwegian Medical Products Agency (Direktoratet for medisinske produkter, DMP).
• In Denmark: the Danish Medicines Agency (Lægemiddelstyrelsen).
• In Finland: the Finnish Medicines Agency (Fimea).

A serious incident is an event that directly or indirectly led, might have led, or might lead to death, a serious deterioration in a person’s state of health, or a serious public-health threat. It must be reported without delay.

15. Access to the complete IFU

A free paper copy of the current IFU can be requested from [email protected] and will be provided within 7 calendar days. Previous versions can be provided on request where required for traceability or safe use.