# NYL: Handpiece, Air-Powered, Root Canal Irrigation

- Device class: 1; regulation: 21 CFR 872.4200; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 181 days (middle half 181–181)
- Recalls: 0 (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)
- 2006: 1
- 2010: 1
- 2014: 1
- 2016: 1
- 2021: 1

## Most-cited predicates
- K140685: Endo Vac Apical Negative Pressure Irigation System (2014), cited by 2
- K211721: PS System (2021), cited by 1
- K052271: Rinsendo (2006), cited by 1

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