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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 K091920
Device Name ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT FOR NOBEL REPLACE IMPLANTS, ATLANTIS GEMINI + ABUTMENT FOR NOBEL
Applicant
Astra Tech, Inc.
8944 Tamaroa Terr.
Skokie,  IL  60076
Applicant Contact BETSY A BROWN
Correspondent
Astra Tech, Inc.
8944 Tamaroa Terr.
Skokie,  IL  60076
Correspondent Contact BETSY A BROWN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/30/2009
Decision Date 09/28/2009
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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