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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 K122192
Device Name NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
Applicant
STRAUMANN USA, LLC
60 minuteman road
andover,  MA  01810
Applicant Contact elaine alan
Correspondent
STRAUMANN USA, LLC
60 minuteman road
andover,  MA  01810
Correspodent Contact elaine alan
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/24/2012
Decision Date 11/02/2012
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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