About Dentio
Controlled labeling, support, and IFU information for the current version.
Content on this page mirrors the Dentio Practice Automation System v1.7.0 in-app label in the About Dentio view. In any conflict, the latest in-app label takes precedence.
Dentio Practice Automation System
DENTIO-SaaS-EU · v1.7.0
Presentation
CE-marked Class I medical device
Dentio is CE-marked as a Class I medical device under Regulation (EU) 2017/745. No notified body identification number accompanies the CE marking (MDR Article 20(5)).
Language notice
The only clinically supported in-app language is Swedish. Regulatory documents and this web page are also available in English for reference.
Product details
| Symbol | Information | Value |
|---|---|---|
| MD | Medical device | Dentio Practice Automation System |
| CE marking | CE-marked Class I medical device |
| Manufacturer | Dentio AB Norrtullsgatan 6, 113 29 Stockholm, Sweden | |
| Date of manufacture (software version release date) | 2026-04-06 | |
| UDI | UDI-DI | 07350183430006 |
 | Electronic instructions for use | Help > About Dentio > Open current IFU Open IFU summary |
Additional product details
- Device model
- DENTIO-SaaS-EU
- Software version
- 1.7.0
- Date of manufacture (software version release date)
- 2026-04-06
- First made available on the Swedish market
- 2026-01-01
- SRN
- SE-MF-000051592
- Basic UDI-DI
- 735018343Dentio_v1AM
Intended purpose
Medical device software intended to assist licensed dental professionals in administration-related tasks such as drafting, structuring, and reviewing clinical administrative documentation by transcribing explicitly stated information and presenting structured content for clinician approval.
Warnings
- All AI-generated content is draft content and must be reviewed, corrected where needed, and explicitly approved by a licensed dentist or dental hygienist before use, saving, export, or transfer.
- Dentio must not be used for diagnosis, treatment decisions, triage, risk assessment, radiograph interpretation, or other clinical decision-making.
- Do not rely solely on AI-generated content. The text may be well-written but still contain errors, omissions, or unsupported information.
Precautions
- Always verify patient, visit, and document type before review, approval, or transfer.
- Use Dentio only within the Swedish market and for Swedish-language documentation drafts.
- If audio, language, source material, or workflow reliability is insufficient, use the clinic’s manual documentation procedure.
Documentation and contact
- Regulatory contact email
- [email protected]
- Official documentation page
- https://www.dentio.com/en/mdr/
- Support path
- Sidebar > Support
Instructions for Use (IFU)
- Full Instructions for Use
- Available in the Dentio application and on request from Dentio.
- Open current IFU
- Help > About Dentio > Open current IFU
- Public summary
- Public IFU summary page Open IFU summary
- Paper copy
- Available on request at no additional cost. Dispatched within 7 calendar days. [email protected]