# EGD: Wax, Dental, Intraoral

- Device class: 1; regulation: 21 CFR 872.6890; FDA's rule: 510(k) exempt
- FDA decisions: 25
- 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)
- 1980: 1
- 1982: 2
- 1985: 1
- 1986: 4
- 1988: 2
- 1989: 6
- 1991: 2
- 1992: 5
- 1995: 1
- 2002: 1

## Most-cited predicates
- K924024: Ortho Wax (1992), cited by 1
- K020009: Brace Eze (2002), cited by 1

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