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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 K103020
Device Name ATLANTIS ABUTMENT FOR KEYSTONE IMPLANT, ATLANTIS GEMINI ABUTMENT
Applicant
Atlantis Components, Inc.
8944 Tamaroa Terrace
Skokie,  IL  60076
Applicant Contact BETSY BROWN
Correspondent
Atlantis Components, Inc.
8944 Tamaroa Terrace
Skokie,  IL  60076
Correspondent Contact BETSY BROWN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/12/2010
Decision Date 02/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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