SMARTDent

SMARTDent is a software solution for managing dental diagnostic images including CT, panoramic, cephalometric, intraoral sensor images, and intraoral camera images. It provides image analysis tools and measurement capabilities to support dental diagnosis by healthcare professionals such as dentists and specialists.

The proposed device differs from the predicate (CS Imaging, K173622) in two areas: supported image formats (SMARTDent adds STL and PLY formats beyond the predicate's DICOM, BMP, JPEG, TIFF, PNG, STL, PLY) and system requirements (SMARTDent specifies Intel i5/i7 processors, 8-32GB RAM, Windows 11, and recommends NVidia GeForce GTX 4060 for 3D viewing; predicate had less demanding specifications). Both devices share identical image measurement tools, viewing modes, manipulation functions, and 3D imaging capabilities.

Not stated in this summary.

SMARTDent is substantially equivalent to CS Imaging because both are medical image management and processing systems in the same regulatory classification (21 CFR 892.2050, Class II, product code LLZ) with identical intended use for managing dental diagnostic images and supporting diagnosis. The functional features—image input sources, measurement tools, viewing layouts, image manipulation, 3D imaging (MPR, cross-section, panoramic, implant views), and annotation capabilities—are the same or equivalent between devices. Differences in image format support and system requirements represent incremental technical improvements that do not alter the fundamental safety and effectiveness profile. Performance testing confirmed equivalence through verification and validation per FDA guidance on device software.