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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K093749
Device Name GC AADVA IMPLANT SYSTEM
Applicant
GC America, Inc.
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Applicant Contact CARL JENKINS
Correspondent
GC America, Inc.
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact CARL JENKINS
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received12/07/2009
Decision Date 12/06/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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