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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 K113003
Device Name ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...
Original Applicant
ASTRA TECH INC.
8944 tamaroa terrace
skokie,  IL  60076
Original Contact betsy a brown
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/07/2011
Decision Date 03/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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