Straumann CARES Visual and Nova Dental CAD

Straumann CARES Visual and Nova Dental CAD is dental design software that creates implant-borne dental restorations by integrating optical scan files from intra-oral or extra-oral scanners with CAD tools. It enables design of two-piece and one-piece abutment components, crowns, bridges, and bars for restoration of partially or fully edentulous patients, with output sent to Straumann manufacturing centers or compatible milling/3D printing devices.

The proposed device requires 16 GB RAM (vs. 8 GB in predicate), runs on Windows 10 64-bit (vs. Windows 7/8/8.1/10), has lower monitor resolution of 1280×800 (vs. 1920×1080), equivalent video memory (1 GB), and uses Intel Core i5 at 3.3 GHz (vs. Core i7). Both share identical core functional features including patient data management, geometry collection and alignment, 3D measurement tools, space/contact analysis, and prosthetic design with export capabilities.

Not stated in this summary.

The device is substantially equivalent because it performs the same intended function as predicate K200100 (abutment design software) with identical core features for designing patient-specific implant abutment components. Although the proposed device has slightly lower hardware requirements (Core i5 vs. i7, lower monitor resolution), these differences do not affect functionality. Software verification and validation testing demonstrated that design restrictions prevent components from exceeding allowable design limitations and that design libraries remain locked against user modification, maintaining the same safety and performance as the predicate. The device integrates multiple components of the digital dentistry workflow in substantially the same manner as cleared reference predicates.