SureSmile Software

SureSmile Software is an orthodontic treatment planning tool that allows clinicians to manage 3D models of patient dentition, perform systematic inspection and detailed analysis, plan treatments, create simulations, and design custom appliance systems including aligners, retainers, brackets, wires, and dental casts. The software serves as both a front-end planning tool and order management system for SureSmile Digital Lab services and requires users to have orthodontic training and dedicated software training.

SureSmile Software has similar technological features to the predicate ArchForm system, including Windows 10 professional/Mac OS X operating systems, 8 GB RAM, 128 GB hard drive space, NVIDIA Quadro graphics, and support for STL and DICOM image formats. It includes software features for patient data management, study material collection and segmentation, alignment, measurement, analysis, 2D/3D simulation, orthodontic appliance search and virtual preparation, virtual appliance design, and appliance export.

The submission references the FDA Guidance document 'Content of Premarket Submissions for Device Software Functions' (issued June 14, 2023) and indicates the software underwent integration and other performance testing. The device is subject to Quality Management System Regulation (21 CFR Part 820), including ISO 13485 clauses for design controls, nonconforming product, and corrective/preventative action.

SureSmile Software is substantially equivalent to the predicate ArchForm Orthodontic Software System (K213916) because it has the same intended use, indications for use statement, classification, and fundamental technology for orthodontic treatment planning and appliance design. The device passed nonclinical performance testing consistent with its intended use, and Table FS.3 demonstrates functional and technological equivalence across all key parameters including features, supported anatomic areas, hardware requirements, and supported image formats.