FDA.reportPublic FDA data

EPIEN MEDICAL, INC.

Matched from indexed company URL: EPIEN Medical Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30034284923003428492EPIEN MEDICAL, INC.1N2026-01-014225 White Bear Parkway SUITE 600 White Bear Lake MN US 55110

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860004740308HYBENX Root Canal Cleanser - EPIEN Root Canal Cleanser is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal system.6516533380customerservice@epien.com
00860004740322HYBENX Advanced Dental Debridement Gel - HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.6516533380Kherland@epien.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
822721066587774K201785EPIEN Dental CleanserKJJ2021-09-09
822721691966561K123538EPIEN ROOT CANAL CLEANSERKJJ2013-02-01
822721587725218

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KJJ22021-09-09

PMN#

GUDID#