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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K111357
Device Name STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
Original Applicant
STRAUMANN USA
60 minuteman road
andover,  MA  01810
Original Contact elaine alan
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/16/2011
Decision Date 10/03/2011
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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