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 Laon Medi, Inc., Celebrace and Dentsply Sirona, Inc..
FDA 510(k) Cleared Orthodontic Software Devices (Product Code PNN)
About Product Code PNN - Regulatory Context
510(k) Submission Activity
33 total 510(k) submissions under product code PNN since 2016, with 33 receiving FDA clearance (average review time: 164 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA Review Time
Recent submissions under PNN have taken an average of 121 days to reach a decision - down from 172 days historically, suggesting improved FDA processing for this classification.
PNN devices are reviewed by the Dental panel. Browse all Dental devices →