Device Dossier
Dental CAD/CAM system application software
Device Dossier for Dental CAD/CAM system application software (CAD/CAM software, Class IIa, sponsor Invisalign). ARTG record, intended purpose, GMDN…
- GMDN category: CAD/CAM software
Intended purpose
ClinCheck Pro software (ClinCheck) is a proprietary 3D computer application (electronic prescription) for depicting, viewing, editing, monitoring, and approving an orthodontic treatment plan, including a virtual representation of the patient’s expected tooth movement from the beginning through final stage of their Invisalign case in a virtual three-dimensional model. ClinCheck software is designed to be available on the treating doctor’s computer and is launched by the system when the user clicks on the ClinCheck file. The software provides a computerized approximation of desired tooth movement for a specific patient and the results are simulated based on the approved ClinCheck treatment plan. The ClinCheck treatment plan includes the ClinCheck model with options such as placement of attachments or a Power Ridge feature and Interproximal Reduction (IPR) if required by the treatment plan. The doctor must review the ClinCheck treatment plans thoroughly. The doctor may make changes or modifications via the ClinCheck software prior to approving the final ClinCheck treatment plan. The doctor’s approval of the customized ClinCheck treatment plan is considered a prescription and constitutes final authorization for Align to manufacture the aligners.