11 devices · 4 companies · 2021 to 2026
Overjet, Inc.: AI-enabled devices on FDA's list
11 devices from Overjet, Inc., 2021 to 2026, from 4 companies across 3 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (10 of 11 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Overjet, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Overjet Iris Intelligent Imaging SystemK253930 · 510(k) | Radiology | QIH | database entry | |
| Overjet CBCT AssistK251514 · 510(k) | Radiology | QIH | database entry | |
| Overjet Image Enhancement AssistK241681 · 510(k) | Radiology | QIH | database entry | |
| Overjet Charting AssistK241684 · 510(k) | Radiology | QIH | database entry | |
| Overjet Caries Assist-PediatricK233738 · 510(k) | Radiology | MYN | database entry | |
| Overjet Charting AssistK233590 · 510(k) | Radiology | QIH | database entry | |
| Overjet Periapical Radiolucency AssistK231678 · 510(k) | Radiology | MYN | database entry | |
| Overjet Caries AssistK222746 · 510(k) | Radiology | MYN | database entry | |
| Overjet Calculus AssistK220928 · 510(k) | Radiology | MYN | database entry | |
| Overjet Caries AssistK212519 · 510(k) | Radiology | MYN | database entry | |
| Overjet Dental AssistK210187 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.