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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 K113283
Device Name NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS
Original Applicant
STRAUMANN USA
60 minuteteman road
andover,  MA  01810
Original Contact elaine alan
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/07/2011
Decision Date 12/28/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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