# Epien Medical, Inc.

- Location (FDA's records): St. Paul, MN
- FDA decisions: 2 (2013–2021): 2 510(k) clearances
- Product codes: KJJ (2)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)
- Dentsply Intl.: 1 (https://510kreport.com/company/dentsply-intl)
- Puricore, Inc.: 1 (https://510kreport.com/company/puricore)

## Recent decisions
- K201785: EPIEN Dental Cleanser (Sep 9, 2021)
- K123538: Epien Root Canal Cleanser (Feb 1, 2013)

Source page: https://510kreport.com/company/epien-medical