# NXC: Aligner, Sequential

- Device class: 2; regulation: 21 CFR 872.5470; FDA's rule: 510(k) required
- FDA decisions: 145
- 510(k) review time 2021–2025: median 103 days (middle half 61–225)
- 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: 3
- 2018: 11
- 2019: 16
- 2020: 16
- 2021: 20
- 2022: 19
- 2023: 13
- 2024: 14
- 2025: 11
- 2026: 5

## Most-cited predicates
- K113618: Clearcorrect System (2012), cited by 16
- K981095: Align System (1998), cited by 9
- K081960: Invisalign System (2008), cited by 9
- K220287: Invisalign System (2022), cited by 6
- K143630: Invisalign System (2015), cited by 5
- K071970: Clear Image Aligner (2007), cited by 5
- K173784: Smylic Invisible Clear Aligners (2018), cited by 5
- K182826: Ormco Spark Aligner System (2018), cited by 5
- K180241: Orthocaps Twinaligner (2018), cited by 4
- K180346: Byte Aligner System (2019), cited by 4

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