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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 K072100
Device Name GC AADVA ABUTMENT
Applicant
GC America, Inc.
1025 Everett Rd.
Suite 100
Lake Forest,  IL  60045
Applicant Contact H. CARL JENKINS
Correspondent
GC America, Inc.
1025 Everett Rd.
Suite 100
Lake Forest,  IL  60045
Correspondent Contact H. CARL JENKINS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/31/2007
Decision Date 02/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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