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Orthodontic Software

FDA product code PNN · 35 cleared devices

Class 2 Dental
Regulation
21 CFR 872.5470
Review panel
DE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2016-04-28 – 2026-09-25

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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