# PNN: Orthodontic Software

- Device class: 2; regulation: 21 CFR 872.5470; FDA's rule: 510(k) required
- FDA decisions: 37
- 510(k) review time 2021–2025: median 90 days (middle half 69–181)
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 2
- 2018: 5
- 2019: 2
- 2020: 7
- 2021: 4
- 2022: 1
- 2023: 3
- 2024: 4
- 2025: 2
- 2026: 6

## Most-cited predicates
- K152086: 3Shape Ortho System (2016), cited by 8
- K171634: Ortho System (2018), cited by 6
- K180941: Ortho System (2018), cited by 5
- K171295: ULab Systems Treatment Planning Software (2018), cited by 3
- K181112: Orchestrate 3D (2018), cited by 2
- K212770: Vision (2021), cited by 2
- K171122: CEREC Ortho Software (2018), cited by 2
- K233625: Raydent SW (2024), cited by 2
- K232564: Align Studio (2024), cited by 1
- K213916: ArchForm Orthodontic Software System (2021), cited by 1

Source page: https://510kreport.com/product-code/PNN
Data by year (CSV): https://510kreport.com/product-code/PNN.csv