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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K113816
Device Name GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV
Applicant
GC AMERICA, INC.
10 E. SCRANTON AVENUE
SUITE 201
LAKE BLUFF,  IL  60044
Applicant Contact CARL H JENKINS
Correspondent
GC AMERICA, INC.
10 E. SCRANTON AVENUE
SUITE 201
LAKE BLUFF,  IL  60044
Correspondent Contact CARL H JENKINS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/27/2011
Decision Date 01/30/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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