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    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

    CE marking
    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

    SymbolInformationValue
    MDMedical deviceDentio Practice Automation System
    CE markingCE markingCE-marked Class I medical device
    ManufacturerDentio AB
    Norrtullsgatan 6, 113 29 Stockholm, Sweden
    Date of manufacture2026-04-06
    UDIUDI-DI07350183430006
    Electronic instructions for useHelp > About Dentio > Open current IFU
    Open IFU summary

    Additional product details

    Device modelDENTIO-SaaS-EU
    Software version1.7.0
    SRNSE-MF-000051592
    Basic UDI-DI735018343Dentio_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.

    All generated content remains a draft until reviewed and explicitly approved by a licensed dentist or dental hygienist. The currently released version is limited to Swedish and to the Swedish market.

    Mandatory review

    All AI-generated content must be reviewed and explicitly approved by a licensed dentist or licensed dental hygienist before use or transfer.

    Documentation and contact

    Regulatory contact email[email protected]
    Official documentation pagehttps://www.dentio.com/en/mdr/
    Support pathSidebar > Support

    Instructions for Use (IFU)

    Current IFUDEN-IFU-001 v0.5
    Open current IFUHelp > About Dentio > Open current IFU
    Public summaryPublic IFU summary page Open IFU summary
    Paper copyAvailable on request at no additional cost. Dispatched within 7 calendar days. [email protected]

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