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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K063856
Device Name EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
Applicant
Essential Dental Systems, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Essential Dental Systems, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number872.3820
Classification Product Code
KIF  
Date Received12/28/2006
Decision Date 02/06/2007
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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