EPIEN Dental Cleanser

Cleanser, Root Canal

EPIEN Medical, Inc.

The following data is part of a premarket notification filed by Epien Medical, Inc. with the FDA for Epien Dental Cleanser.

Pre-market Notification Details

Device IDK201785
510k NumberK201785
Device Name:EPIEN Dental Cleanser
ClassificationCleanser, Root Canal
Applicant EPIEN Medical, Inc. 4225 White Bear Parkway Suite 600 St. Paul,  MN  55110
ContactReginald Dupre
CorrespondentCarmelina G. Allis
The Allis Law Firm, PLLC 2532 North Fourth Street, #620 Flagstaff,  AZ  86004
Product CodeKJJ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-30
Decision Date2021-09-09

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