| K-number | K252507 |
| Device name | SmileInspector |
| Applicant | Amv Consulting, LLC |
| Product code | PNN |
| Device class | Class II |
| Decision date | Jan 7, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.5470 |
SmileInspector is orthodontic planning and treatment simulation software used by dental professionals. It allows users to upload 3D digital scans of patient teeth, analyze and measure them, simulate tooth movements, plan treatment, and export virtual dental casts in STL format for manufacturing sequential aligner trays or retainers. The software can be used before, during, and after orthodontic treatment to inspect progress and evaluate outcomes.
SmileInspector supports Windows 10+ and macOS 12+ with 8GB RAM (16GB recommended) and WebGL 2.0 GPU support. It accepts STL, OBJ, PLY, and DICOM digital data formats. The software includes 3D measurement tools, analysis features (arch shape, tooth width, Bolton Analysis, space analysis, overjet/overbite, occlusion mapping), 3D treatment simulation, and patient case management. Minor differences from the predicate include support for CBCT scans and DICOM format input, versus the predicate's 2D overlays and image formats.
Software verification and validation testing was conducted per FDA Guidance for Industry and FDA Staff 'Guidance for the Content of Premarket Submission for Software Contained in Medical Device.' Cybersecurity risks were addressed in accordance with FDA Guidance Document 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.' The device documentation level was determined to be Basic Documentation level for moderate-level-of-concern software.
SmileInspector is substantially equivalent to predicate device Vision (K212770) because both are Class II software-only devices with identical intended uses in orthodontic treatment planning, identical product codes (PNN, LLZ), identical regulatory classification (21 CFR 872.5470), and very similar technological characteristics. Minor differences in supported file formats and system requirements do not raise new safety or effectiveness questions, as confirmed by risk analysis and verification/validation testing demonstrating that SmileInspector performs as intended.
View the full FDA submission: accessdata.fda.gov