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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 K121131
Models 021.4308,021.4310,021.4312,021.4314, 021.6308,021.6310,021.6312,021.6314
Device Name BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
Original Applicant
STRAUMANN USA
60 minuteman road
andover,  MA  01810
Original Contact elaine alan
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/13/2012
Decision Date 06/06/2012
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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