Caries Assist
Overjet · Bitewing radiographs · Data processed in United States (FDA)
Concurrent-read detection software for the detection and segmentation of caries on bitewing radiographs, in patients aged 18 and over. Cleared 10 May 2022. The vendor states the product is not fully sensitive and that the clinical determination remains the clinician's.
FDA 510(k) K212519 (Overjet, Inc.)
How access works
This platform is documented in our catalogue. We assess technical fit and handle the introduction; the commercial agreement is signed directly with the vendor.