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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
Models 024.2372, 024.4372, 048.242, 048.664, 048.699
Device Name NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
Original Applicant
STRAUMANN USA, LLC
60 minuteman road
andover,  MA  01810
Original Contact elaine alan
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/24/2012
Decision Date 11/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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