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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Root Canal
510(k) Number K201785
Device Name EPIEN Dental Cleanser
Applicant
EPIEN Medical, Inc.
4225 White Bear Parkway Suite 600
St. Paul,  MN  55110
Applicant Contact Reginald Dupre
Correspondent
The Allis Law Firm, PLLC
2532 North Fourth Street, #620
Flagstaff,  AZ  86004
Correspondent Contact Carmelina G. Allis
Classification Product Code
KJJ  
Date Received06/30/2020
Decision Date 09/09/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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