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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 K132214
Device Name ABUTMENT RP, ABUTMENT WP, BURN-OUT COPING, SCREWS, TITANIUM ADHESIVE BASE, ALLIGATOR ABUTMENT, SOLID ABUTMENT, RETENTIVE
Applicant
Hager& Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE D-41468
Applicant Contact WIEBKE STOLTEN
Correspondent
Hager& Meisinger GmbH
Hansemannstrasse 10
Neuss,  DE D-41468
Correspondent Contact WIEBKE STOLTEN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/16/2013
Decision Date 07/07/2014
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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