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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 K062277
Device Name ATLANTIS ABUTMENT IN ZIRCONIA FOR NOBEL BIOCARE REPLACE
Applicant
Atlantis Components, Inc.
8944 Tamaroa Ter.
Skokie,  IL  60076
Applicant Contact FRANKLIN UYLEMAN
Correspondent
Atlantis Components, Inc.
8944 Tamaroa Ter.
Skokie,  IL  60076
Correspondent Contact FRANKLIN UYLEMAN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/07/2006
Decision Date 12/20/2006
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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