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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 K140846
Device Name EDS COMBO-RINSE
Applicant
Essential Dental Systems, Inc.
89 Leuning St., Suite 8
South Hackensack,  NJ  07606
Applicant Contact JEFFREY WAN
Correspondent
Essential Dental Systems, Inc.
89 Leuning St., Suite 8
South Hackensack,  NJ  07606
Correspondent Contact JEFFREY WAN
Classification Product Code
KJJ  
Date Received04/03/2014
Decision Date 07/25/2014
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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