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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 K051652
Device Name ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, 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 Received06/21/2005
Decision Date 07/22/2005
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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