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.
| Registration Number | 3003428492 | 
| FEI Number | 3003428492 | 
| Name | EPIEN MEDICAL, INC. | 
| Owner & Operator | EPIEN MEDICAL, INC. | 
| Contact Address | 4225 White Bear Parkway SUITE 600 White Bear Lake MN 55110 US | 
| Official Correspondent | 
 | 
| Registration Status | 1 | 
| Initial Importer | N | 
| Registration Expiration | 2020-04-25 | 
| Registration Address | 4225 White Bear Parkway SUITE 600 White Bear Lake, MN 55110 US | 
| Establishment Type | 
 | 
| Device Company | Device | Date | 
|---|---|---|
| Epien Medical, Inc. | HYBENX Advanced Dental Debridement Gel 109-0004 | 2023-05-17 | 
| Epien Medical, Inc. | HYBENX Advanced Dental Debridement 109-0001 | 2023-05-16 | 
| EPIEN Medical Inc | Prescription Medication | 2021-12-01 | 
| EPIEN Medical, Inc. | EPIEN Dental Cleanser | 2021-09-09 | 
| Epien Medical, Inc. | HYBENX Root Canal Cleanser | 2021-05-28 | 
| EPIEN Medical Inc | Prescription Medication | 2020-12-02 | 
| EPIEN Medical Inc | Prescription Medication | 2019-11-20 | 
| EPIEN Medical Inc | Prescription Medication | 2018-12-28 | 
| EPIEN MEDICAL, INC. | HYBENX Oral Decontaminant | 2013-05-20 | 
| EPIEN MEDICAL, INC. | HRCC HybenX Root Canal Cleanser | 2013-05-20 | 
| EPIEN MEDICAL, INC. | ERCC EPIEN Root Canal Cleanser | 2013-05-20 | 
| EPIEN MEDICAL, INC. | EPIEN ROOT CANAL CLEANSER | 2013-02-01 | 
| EPIEN MEDICAL, INC. | ORAL MEDIC | 2006-06-16 | 
| EPIEN MEDICAL, INC. | HYBENX | 2006-06-16 | 
| EPIEN MEDICAL, INC. | APTHE RELIEF (FOR EXPORT ONLY) | 2006-06-16 | 
| EPIEN Medical Inc | DEBACTEROL Canker Sore Pain Relief | 1996-09-01 | 
| NCAGE Code | 1X8M9 | EPIEN MEDICAL, INC. | 
| CAGE Code | 1X8M9 | EPIEN MEDICAL, INC. | 
| S.A.M. Registration | 1X8M9 [128678765] | EPIEN MEDICAL, INC. |