# EBW: Controller, Foot, Handpiece And Cord

- Device class: 1; regulation: 21 CFR 872.4200; FDA's rule: 510(k) required
- FDA decisions: 62
- 510(k) review time 2021–2025: median 273 days (middle half 245–479)
- 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)
- 2016: 1
- 2017: 4
- 2018: 1
- 2019: 2
- 2020: 1
- 2021: 2
- 2022: 6
- 2024: 4
- 2025: 3
- 2026: 3

## Most-cited predicates
- K052741: Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. Accessories (2006), cited by 8
- K161957: W&H Implantmed SI-1015 incl. Accessories (2016), cited by 4
- K031584: Sirotorque L (2003), cited by 4
- K163131: A-dec NLZ Electric Motor System (2017), cited by 4
- K173905: Surgic Pro, Surgic Pro+ (2018), cited by 4
- K103653: E3 Torque Control Motor (2011), cited by 3
- K181858: Electric Handpiece Motor (2019), cited by 3
- K161213: XSmart iQ (2017), cited by 2
- K002469: Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) (2001), cited by 2
- K133776: A-Dec/W&H Electric Handpiece Motor (2014), cited by 2

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