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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 K052070
Device Name ATLANTIS ABUTMENT IN ZIRCONIA, ATLANTIS GEMINI ABUTMENT IN ZIRCONIA, ATLANTIS GEMEINI + ABUTMENT IN ZIRCONIA
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 Received08/01/2005
Decision Date 10/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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