# EAZ: Light, Operating, Dental

- Device class: 1; regulation: 21 CFR 872.4630; FDA's rule: 510(k) exempt
- FDA decisions: 23
- Recalls: 2 (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)
- 1989: 4
- 1990: 1
- 1991: 2
- 1992: 1
- 1993: 2
- 1994: 1
- 2001: 1
- 2004: 1
- 2005: 1
- 2007: 1

## Most-cited predicates
- K003995: Speculite/Orallite (2001), cited by 3
- K033033: Vizilite-Blue Oral Exam Kit (2004), cited by 1

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