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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 K133421
Device Name STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
Applicant
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Applicant Contact CHARLOTTE RINGLEB
Correspondent
Straumann USA, LLC
6 0 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact CHARLOTTE RINGLEB
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/08/2013
Decision Date 04/17/2014
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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