Device type
Orthodontic Software
Product code PNN · Class II · 21 CFR 872.5470 · Dental
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.
Recent 510(k)s
Oct 23, 2026
K260421
LuxDesign
LuxCreo, Inc.
- PNN
- Class II
Oct 7, 2026
K262378
Dr.AlignNavi
InnoDtech, Inc.
- PNN
- Class II
Sep 25, 2026
K262196
Invisalign System
Align Technology, Inc.
- PNN
- Class II
Recent recalls
No recalls in the archive for PNN.