PNN · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5470
Classification
FDA Product Code
PNN
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.5470
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.