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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 K101004
Device Name ATLANTIS ABUTMENT FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT
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 Received04/12/2010
Decision Date 08/16/2010
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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