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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
Applicant
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact ELAINE ALAN
Correspondent
STRAUMANN USA
60 MINUTETEMAN ROAD
ANDOVER,  MA  01810
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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