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Align X-ray Insights

by dentalXrai

AI Application
Low Confidence

Align X-ray Insights, formerly dentalXrai Pro, is cloud-based software for dental practices that analyses 2D dental X-rays. The vendor describes it as a software-only computer-aided detection (CADe) device: its AI automatically analyses the radiograph and annotates suspected findings such as caries, periapical radiolucencies and periodontal bone loss with colour-coded overlays, fills in an interactive tooth chart and produces a report that the dentist can share with the patient. Align says the software is intended to be used together with the dentist's own evaluation and should not be relied upon alone to make or confirm a diagnosis, and that the available detections vary by market. It runs from a desktop or tablet browser or through an integration with Align's iTero intraoral scanner. The vendor does not state where images are processed or hosted. Align Technology bought the original developer, dentalXrai GmbH of Berlin, in 2022; EUDAMED still lists dentalXrai GmbH as the manufacturer.

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Transparency Score

Weighted across four pillars · updated October 20, 2026

Overall grade
20% weighted
ABCDF
Model
—
Not yet assessed
Infrastructure
—
Not yet assessed

Capabilities

Caries Detection
Periapical Lesion Detection
Bone Loss Detection
Tooth Charting
Patient Report Generation

Vendor Information

Complete information about the vendor/provider of this AI application

dentalXraiView all products →
dentalXrai GmbH(Trading as: Align Technology)
Contact Information
www.alignxrayinsights.com
Registered Address
Budapester Straße 35, Berlin, Berlin, 10787, DE

EU AI Act Provider Information

Verification Status:
Unverified
dentalXrai GmbH(Trading as: Align Technology)
Budapester Straße 35, Berlin, Berlin, 10787, DE
Compliance Documents
CE Marking: Certified
Align says X-ray Insights is 'intended to be used in conjunction with an evaluation by the doctor', 'should not be solely relied upon to make or confirm a diagnosis', and that 'Available detections may vary within the different markets' (https://www.alignxrayinsights.com/, read 2026-10-20). A German market notice repeats that it is meant for use together with a clinical examination (https://www.zm-online.de/markt/marktanzeigen/detail/neu-align-x-ray-insights, read 2026-10-20). No contraindications are published.
Compliance & Risk

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Added: October 20, 2026
Updated: October 20, 2026

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