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Sign in to claim this brandEpien Medical, Inc.
United States·US-MF-000008278
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 4225, White Bear Parkway, Suite 600, St. Paul, United States
- Website
- www.epien.com
- —
- —
- [email protected]
- Phone
- +1-651-243-7886
- PRRC Contact
- Toni Pugsley
- EUDAMED SRN
- US-MF-000008278
- FDA FEI Number
- 3003428492
- DUNS Number
- 128678765
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HYBENX Root Canal Cleanser | 101-2002 | FDA UDI | U | Unknown |
| HybenX® OTD Gel | 103-5002 | EUDAMEDFDA UDI | Class I | Active |
| Oralmedic | 105-0005 | EUDAMED | Class I | Active |
| HybenX® OTD | 103-2001 | EUDAMEDFDA UDI | Class I | Active |
| Epien Root Canal Cleanser | K123538 | FDA 510(k) | U | Active |
| EPIEN Dental Cleanser | K201785 | FDA 510(k) | U | Active |
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Authorised Representatives
- Qnet B.v. NL
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