Intended Use

Overjet Charting Assist is a Medical Image Management and Processing System intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. It assists dental professionals in producing dental charts based on image analysis from bitewing, periapical, and panoramic radiographs for patients ages 5 and above.

Technology

The system uses AI-based image analysis to detect specific dental structures on 2D dental radiographs (bitewing, periapical, panoramic). It includes a Predetermined Change Control Plan (PCCP) for iterative algorithm updates based on real-world data to reduce false positives and negatives. Algorithm modifications are applied manually and undergo verification and validation before release, with no continuous learning in the field.

Performance

No additional performance testing was conducted for this updated device apart from the existing data from the predicate device. Performance assessments follow previously established acceptance criteria to ensure safety and effectiveness. If modifications fail performance evaluation, they are not implemented.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/11/2024

    2 months
  • 2

    FDA Approval

    8/27/2024

Other devices from Overjet, Inc

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