LingOral Dental Design System

LingOral is a software designed to assist dental professionals in planning patient treatment and designing treatment devices. It performs simulations based on patient images to create treatment plans and design prosthetic devices (veneer, crown, bridge, inlay/onlay) and orthodontic devices (clear aligners). Users must have appropriate education and training in orthodontic or prosthodontic practice.

LingOral supports DICOM and 3D image formats (PLY, OBJ, STL) with hardware requirements including multi-core x86-64 processors, minimum 16GB RAM, discrete GPU with CUDA support, and 512GB SSD storage. It runs on Windows 10+, macOS 10.15+, or Linux. The predicate device RAYDENT SW has similar core specifications but slightly different minimum hardware (Intel Core i5, 16GB RAM, RTX 2060). Both devices include AI/ML capabilities; the proposed device lacks prosthesis design functionality present in the predicate.

Software, hardware, and integration verification and validation testing was performed in accordance with FDA Guidance for Device Software Functions and FDA Guidance for Cybersecurity in Medical Devices. The validation suite included mitigation of device hazards identified in risk management procedures. Quality Management System Regulation (QMSR) requirements per 21 CFR Part 820 apply.

The proposed device is substantially equivalent because it performs the same core functions as the predicate device RAYDENT SW (image acquisition, model creation, alignment, measurement, analysis, orthodontic simulation, and appliance design) with identical indications for use. Minor differences in hardware requirements and the absence of prosthesis design functionality do not affect safety and efficacy. All test results confirmed substantial equivalence.