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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 K123538
Device Name EPIEN ROOT CANAL CLEANSER
Applicant
Epien Medical, Inc.
700 Thirteenth St. NW Stuite 200
Washington,  DC  20005
Applicant Contact JEFFREY K SHAPIRO
Correspondent
Epien Medical, Inc.
700 Thirteenth St. NW Stuite 200
Washington,  DC  20005
Correspondent Contact JEFFREY K SHAPIRO
Classification Product Code
KJJ  
Date Received11/16/2012
Decision Date 02/01/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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