Data / Medical devices / United States / Epien Medical, Inc.
Epien Medical, Inc.: FDA-registered device maker in White Bear Lake, MN, United States, 2 510(k) clearances
Epien Medical, Inc. is registered with the FDA (registration 3003428492) in White Bear Lake, MN, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 9, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003428492
- Address
- 4225 White Bear Parkway SUITE 600, White Bear Lake, MN, United States, 55110
- Owner or operator
- EPIEN MEDICAL, INC. (9088699)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- June 16, 2006
- Registered through
- 2026
- Brand names listed
- APTHE RELIEF (FOR EXPORT ONLY), ERCC EPIEN Root Canal Cleanser, HRCC HybenX Root Canal Cleanser, HYBENX, ORAL MEDIC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bandage, Liquid, Skin Protectant | NEC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cleanser, Root Canal | KJJ | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 9, 2021 | K201785 | EPIEN Dental Cleanser | KJJ | Substantially Equivalent | Epien Medical, Inc. | accessdata.fda.gov |
| February 1, 2013 | K123538 | EPIEN ROOT CANAL CLEANSER | KJJ | Substantially Equivalent | Epien Medical, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 9, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.