FDA Grants 510(k) Clearance to Pearl’s AI Software for Dental X-Rays

Los Angeles, Calif.-based dental software company Pearl has received the FDA’s 510(k) clearance for Second Opinion, its artificial intelligence-based pathology detection software.

The software, which has also received CE mark certification, is intended to help dentists identify a broad range of common dental conditions in patient X-rays, such as tooth decay, calculus and root abscesses.

The software also highlights nonpathological details, such as discrepancies at the margin of existing restorations, crowns, fillings, root canals, bridges and implants.