# EFW: Toothbrush, Manual

- Device class: 1; regulation: 21 CFR 872.6855; FDA's rule: 510(k) exempt
- FDA decisions: 49
- 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)
- 1995: 2
- 1997: 1
- 1998: 3
- 1999: 1
- 2000: 2
- 2002: 2
- 2008: 1
- 2011: 1
- 2012: 1
- 2013: 1

## Most-cited predicates
- K073224: Oral-B Sub-Brand Manual Toothbrush (2008), cited by 2
- K950993: Butler G.U.M. Antibacterial Toothbrush (1995), cited by 2
- K973236: Crest Toothbrush with Microshield (1998), cited by 1
- K971589: Reach Antibacterial Toothbrush (1997), cited by 1
- K020776: Medoral Hygienic Toothbrush with Dentosan Filaments (2002), cited by 1

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