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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 K113606
Model 048.593
Device Name NNC GOLD ABUTMENT FOR BRIDGES
Original Applicant
STRAUMANN USA
60 minuteman road
andover,  MA  01810
Original Contact elaine alan
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/06/2011
Decision Date 01/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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