Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Overjet Inc. with 12 510(k) clearances and 11 AI-enabled devices. The most recent is a 510(k) clearance dated Aug 6, 2026: Overjet Multi-Image Caries and Charting Assist.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Aug 6, 2026 | Overjet Multi-Image Caries and Charting AssistK261059 · MYN | 510(k) clearances |
| Apr 10, 2026 | Overjet Iris Intelligent Imaging SystemK253930 · QIH | 510(k) clearances |
| Apr 10, 2026 | Overjet Iris Intelligent Imaging SystemK253930 · Radiology | AI-enabled devices |
| Dec 5, 2025 | Overjet CBCT AssistK251514 · QIH | 510(k) clearances |
| Dec 5, 2025 | Overjet CBCT AssistK251514 · Radiology | AI-enabled devices |
| Sep 9, 2024 | Overjet Image Enhancement AssistK241681 · QIH | 510(k) clearances |
| Sep 9, 2024 | Overjet Image Enhancement AssistK241681 · Radiology | AI-enabled devices |
| Aug 27, 2024 | Overjet Charting AssistK241684 · QIH | 510(k) clearances |
| Aug 27, 2024 | Overjet Charting AssistK241684 · Radiology | AI-enabled devices |
| Mar 4, 2024 | Overjet Caries Assist-PediatricK233738 · MYN | 510(k) clearances |
| Mar 4, 2024 | Overjet Caries Assist-PediatricK233738 · Radiology | AI-enabled devices |
| Feb 23, 2024 | Overjet Charting AssistK233590 · QIH | 510(k) clearances |
| Feb 23, 2024 | Overjet Charting AssistK233590 · Radiology | AI-enabled devices |
| Sep 21, 2023 | Overjet Periapical Radiolucency AssistK231678 · MYN | 510(k) clearances |
| Sep 21, 2023 | Overjet Periapical Radiolucency AssistK231678 · Radiology | AI-enabled devices |
| Mar 27, 2023 | Overjet Caries AssistK222746 · Radiology | AI-enabled devices |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
