# SHI: Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

- Device class: 2; regulation: 21 CFR 872.3660; FDA's rule: 510(k) required
- FDA decisions: 4
- 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)
- 2026: 4

## Most-cited predicates
- K251724: Remi Impression Material (2026), cited by 1

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