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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 K103234
Device Name GC AADVA BO AC ABUTMENTS
Applicant
GC AMERICA, INC.
10 E. SCRANTON AVENUE
SUITE 201
LAKE BLUFF,  IL  60044
Applicant Contact CARL JENKINS
Correspondent
GC AMERICA, INC.
10 E. SCRANTON AVENUE
SUITE 201
LAKE BLUFF,  IL  60044
Correspondent Contact CARL JENKINS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/02/2010
Decision Date 06/30/2011
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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