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    About Dentio

    Controlled labeling, support, and IFU information for the current version.

    Bemærk: Dentio er i øjeblikket kun lanceret på det svenske marked, og dette dokument er tilgængeligt på engelsk og svensk. Indholdet nedenfor er det officielle dokument på udgivelsessprog.

    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 manufacture (software version release date)2026-04-06
    UDIUDI-DI07350183430006
    Electronic instructions for useHelp > 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/da/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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