# EKZ: Unit, Electrosurgical, And Accessories, Dental

- Device class: 2; regulation: 21 CFR 872.4920; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 278 days (middle half 278–278)
- 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)
- 1994: 1
- 1995: 1
- 1996: 2
- 1998: 2
- 2000: 2
- 2002: 1
- 2003: 1
- 2005: 2
- 2007: 2
- 2022: 1

## Most-cited predicates
- K962445: Arthrocare Dental Electrosurgery System (1996), cited by 6
- K050735: MC6A (2005), cited by 2
- K950239: Sensimatic 500SE (1995), cited by 2
- K850666: Strobex Ultron Electrosurge-Dental Unit (1985), cited by 1
- K955176: Dento-Surge (1996), cited by 1
- K020080: Bonart Art-E1 Electrosurgery Unit (2002), cited by 1
- K000768: Wallach Quantum 500 Electrosurgical Generator (2000), cited by 1

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