Pure Global AI
FDA product code PNN

Orthodontic Software

DentalClass 221 CFR 872.5470
Verified
US regulatory classifications
US Product Code (FDA)
PNN
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 872.5470
View CFR Regulation
Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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01orthodontic software02dental software03practice management04imaging software05treatment planning06patient management07dental PACS08digital orthodontics09dental charts10CAD software
About this record

Orthodontic Software is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.