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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 K132844
Device Name STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
Applicant
STRAUMANN USA, LLC
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
STRAUMANN USA, LLC
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/11/2013
Decision Date 01/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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