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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K152691
Device Name EDS Universal Cement
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
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/21/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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