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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 K153231
Device Name G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
Applicant
GC America, Inc.
3737 W 127th St.
Alsip,  IL  60803
Applicant Contact Mark Heiss
Correspondent
GC America, Inc.
3737 W 127th St.
Alsip,  IL  60803
Correspondent Contact Mark Heiss
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/09/2015
Decision Date 07/06/2016
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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