Smile Dx®

Smile Dx® is a computer-assisted detection (CADe) software designed to help dentists review digital bitewing and periapical radiographs of permanent teeth. It uses machine learning to detect and segment suspected dental findings including caries, periapical radiolucencies, restorations, and normal anatomy, and to measure mesial and distal bone levels. The device is not intended to replace the dentist's clinical judgment.

Smile Dx® is a web-based application compatible with Edge, Chrome, Firefox, and Safari browsers on any operating system. It accepts radiographic images in multiple formats (jpg, png, tif, dex, gif, bitmap, raw) manually imported from a local computer. The device uses computer vision machine learning algorithms to classify images as bitewing or periapical, then annotates them with contour segmentations for caries and periapical radiolucencies, color-coded boundary lines for bone levels, and displays results with adjustable image settings (brightness, contrast, opacity).

Not stated in this summary.

Smile Dx® shares the same indications for use, regulatory classification (Class II, 21 CFR 892.2070), and primary product code (MYN) as the predicate device Overjet Caries Assist. Both employ machine learning algorithms to aid detection of dental findings on intra-oral radiographs and undergo similar MRMC clinical evaluation demonstrating statistically significant reader improvement. Technological differences—such as manual versus automatic image upload and minor differences in supported image formats and marker types—do not raise new safety or effectiveness questions because they do not impede the device's ability to fulfill its intended detection and measurement purpose. Performance testing shows Smile Dx® achieves comparable or superior results to predicate devices.