# QRY: Dental Navigation System

- Device class: 2; regulation: 21 CFR 872.4120; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 166 days (middle half 108–224)
- Recalls: 1 (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)
- 2022: 3
- 2024: 1
- 2026: 2

## Most-cited predicates
- K222049: Yomi Robotic System (2022), cited by 1
- K211701: X-Guide® Surgical Navigation System (2022), cited by 1
- K232148: X-Guide Surgical Navigation System (2024), cited by 1
- K222750: Yomi Robotic System (2022), cited by 1

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