Um Dentio

Upplýsingar um vörumerkingu, þjónustu og notkunarleiðbeiningar fyrir núverandi útgáfu.

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)).

Upplýsingar um tungumál

Dentio er sem stendur í boði í Noregi, Svíþjóð, Danmörku og Finnlandi. Núverandi útgáfa styður klíníska skráningu á sænsku, norsku, dönsku og finnsku. Vörumerkingin hér að neðan er birt á ensku.

Product details

Symbol	Information	Value
MD	Medical device	Dentio Practice Automation System
	CE marking	CE-marked Class I medical device
	Manufacturer	Dentio AB Sveavägen 28-30, 111 34 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 in Norway, Sweden, Denmark, or Finland and for documentation drafts in Swedish, Norwegian, Danish, or Finnish.
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/is/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]

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