# EJF: Bracket, Metal, Orthodontic

- Device class: 1; regulation: 21 CFR 872.5410; FDA's rule: 510(k) exempt
- FDA decisions: 103
- Recalls: 4 (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)
- 1985: 2
- 1987: 3
- 1988: 7
- 1989: 25
- 1990: 22
- 1991: 7
- 1992: 6
- 1993: 10
- 1994: 12
- 2000: 1

## Most-cited predicates
- K852179: Ceramic Orthodonit Appliance (1985), cited by 2
- K922499: Reflections - Ceramic Dental Bracket (1992), cited by 2
- K900678: The Myoloc System (1990), cited by 1
- K894781: Optiflex (1989), cited by 1

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