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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 K063734
Device Name ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN INTERFACE
Applicant
ATLANTIS COMPONENTS, INC.
8944 TAMAROA TERRACE
SKOKIE,  IL  60076
Applicant Contact BETSY A BROWN
Correspondent
ATLANTIS COMPONENTS, INC.
8944 TAMAROA TERRACE
SKOKIE,  IL  60076
Correspondent Contact BETSY A BROWN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/18/2006
Decision Date 03/02/2007
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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