Better Diagnostics Caries Assist (BDCA) Version 1.0

Better Diagnostics Caries Assist (BDCA) Version 1.0 is an FDA 510(k)-cleared medical device (K241725) manufactured by Better Diagnostics AI Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 2025. Regulation: 8.