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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K896693
Device Name FLEXI-CAST CROWN CORE SYSTEM
Applicant
Essential Dental Systems, Inc.
7 W. 36th St.
New York,  NY  10018
Applicant Contact R MARSHALL,PHD
Correspondent
Essential Dental Systems, Inc.
7 W. 36th St.
New York,  NY  10018
Correspondent Contact R MARSHALL,PHD
Regulation Number872.3810
Classification Product Code
ELR  
Date Received11/28/1989
Decision Date 02/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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