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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 K151247
Device Name NC Straumann Screw Retained Abutments
Applicant
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact CHRISTOPHER KLACZYK
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/11/2015
Decision Date 08/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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