Intended Use

Designed for use by specialized dental practices for storing and presenting patient images and assisting in treatment planning. Results produced by the software's treatment planning tools are dependent on the interpretation of trained and licensed practitioners.

Technology

Software-only device that analyzes 2D cephalogram images input in common image formats. It digitizes landmarks, traces structures, measures distances, provides superimpositions and visualized treatment objectives. Available as locally hosted or cloud-hosted application, it supports orthodontic treatment planning through automatic landmark detection and custom analyses.

Performance

Non-clinical testing including unit, performance, manual, integration, system and regression testing were performed and met acceptance criteria. Automatic landmark detection accuracy was validated against manual landmark placement and passed acceptance thresholds. Clinical performance testing was not required to demonstrate substantial equivalence with the predicate.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/26/2024

    8 months
  • 2

    FDA Approval

    5/30/2025

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