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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 K150020
Device Name Irritrol, EDS Combo-Rinse
Applicant
ESSENTIAL DENTAL SYSTESM, INC.
89 LEUNING STREET, SUITE 8
SOUTH HACKENSACK,  NJ  07606
Applicant Contact JEFFREY WAN
Correspondent
ESSENTIAL DENTAL SYSTESM, INC.
89 LEUNING STREET, SUITE 8
SOUTH HACKENSACK,  NJ  07606
Correspondent Contact JEFFREY WAN
Classification Product Code
KJJ  
Date Received01/06/2015
Decision Date 02/25/2015
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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