DeviceClearance

Product code PNN— Dental

Ortho System

Classification name
Orthodontic Software
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Total cleared
34
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code PNN under 21 CFR 872.5470, via openFDA

Market context for product code PNN

FDA has cleared 34 devices under product code PNN between 2016 and 2026, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PNN

Recent clearances under product code PNN

Data sourced from openFDA. This site is unofficial and independent of the FDA.