FDA Product Code PNN: Orthodontic Software
The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.
Leading manufacturers include Ray Co., Ltd. and Dentsply Sirona, Inc..
List of Orthodontic Software devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Orthodontic Software devices (product code PNN). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Dental FDA review panel. Browse all Dental devices →