# EKX: Handpiece, Direct Drive, Ac-Powered

- Device class: 1; regulation: 21 CFR 872.4200; FDA's rule: 510(k) required
- FDA decisions: 90
- 510(k) review time 2021–2025: median 246 days (middle half 179–337)
- 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)
- 2017: 2
- 2018: 3
- 2019: 3
- 2020: 1
- 2021: 5
- 2022: 3
- 2023: 4
- 2024: 4
- 2025: 5
- 2026: 1

## Most-cited predicates
- K970339: Tri Auto ZX (1997), cited by 7
- K082523: Osstell Isq Implant Stability Meter (2008), cited by 5
- K090931: Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor (2009), cited by 4
- K031204: Dentaport ZX (2003), cited by 4
- K170275: Tri Auto ZX2 (2017), cited by 3
- K092614: X-Smart Easy (2009), cited by 3
- K111616: E-CUBE (2011), cited by 3
- K143445: Tellos ISQ Buddy (2016), cited by 3
- K071190: Root ZX II (2007), cited by 3
- K110753: Midwest RDH Freedom Cordless Prophy System (2011), cited by 3

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