# LWM: Device, Electrical Dental Anesthesia

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 15
- 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)
- 1987: 1
- 1988: 1
- 1989: 1
- 1990: 2
- 1992: 3
- 1994: 3
- 2001: 1
- 2019: 1
- 2020: 2

## Most-cited predicates
- K182947: Dental Pain Eraser (2019), cited by 2
- K915717: Cedeta (1992), cited by 1

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