Laon Ortho

Laon Ortho is a PC-based software system for orthodontic treatment planning that manages 3D dental models, performs systematic inspection and detailed analysis, simulates tooth movement, and enables virtual appliance design. It requires users to have orthodontic training and domain knowledge plus dedicated software training.

Laon Ortho is a stand-alone software module that imports scanned STL files and CT/DICOM images, performs tooth-gingiva segmentation, supports manual and automatic simulation modes for treatment planning, and enables virtual planning of tooth movement. The key difference from the predicate is the addition of an Automatic Simulation Mode alongside the existing Manual Mode.

Not stated in this summary.

The device is substantially equivalent because although Laon Ortho adds an Automatic Simulation Mode not present in predicate Align Studio (K232564), verification and validation testing demonstrated that the Automatic Mode achieves the same treatment planning outcomes as the existing Manual Mode workflow. This addition does not alter the fundamental workflow or adversely affect safety and effectiveness, and the device retains all other features, indications, and intended use identical to the predicates.