Epien Medical Inc

FDA Filings

This page includes the latest FDA filings for Epien Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3003428492
FEI Number3003428492
NameEPIEN MEDICAL, INC.
Owner & OperatorEPIEN MEDICAL, INC.
Contact Address4225 White Bear Parkway SUITE 600
White Bear Lake MN 55110 US
Official Correspondent
  • REGINALD - DUPRE
  • x-651-6533380-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4225 White Bear Parkway SUITE 600
White Bear Lake, MN 55110 US
Establishment Type
  • Manufacture Device in the United States for Export Only
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
EPIEN Medical, Inc.
EPIEN Dental Cleanser2021-09-09
Epien Medical, Inc.
HYBENX Root Canal Cleanser 2021-05-28
EPIEN Medical Inc
Prescription Medication2020-12-02
EPIEN Medical Inc
Prescription Medication2019-11-20
EPIEN Medical Inc
Prescription Medication2018-12-28
EPIEN MEDICAL, INC.
HYBENX Oral Decontaminant2013-05-20
EPIEN MEDICAL, INC.
HRCC HybenX Root Canal Cleanser2013-05-20
EPIEN MEDICAL, INC.
ERCC EPIEN Root Canal Cleanser2013-05-20
EPIEN MEDICAL, INC.
EPIEN ROOT CANAL CLEANSER2013-02-01
EPIEN MEDICAL, INC.
ORAL MEDIC2006-06-16
EPIEN MEDICAL, INC.
HYBENX2006-06-16
EPIEN MEDICAL, INC.
APTHE RELIEF (FOR EXPORT ONLY)2006-06-16
EPIEN Medical Inc
DEBACTEROL Canker Sore Pain Relief1996-09-01

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