# EBH: Material, Impression Tray, Resin

- Device class: 1; regulation: 21 CFR 872.3670; FDA's rule: 510(k) exempt
- FDA decisions: 30
- 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)
- 1985: 5
- 1986: 1
- 1987: 1
- 1988: 4
- 1989: 1
- 1990: 2
- 1991: 2
- 1992: 2
- 1993: 1
- 1994: 1

## Most-cited predicates
- K881838: Modified Permagum Adhesive (1988), cited by 1

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