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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 K173968
Device Name Straumann Variobase for Bridge/Bar Cylindrical
Applicant
Institut Straumann AG
Lochhamer Schlag 6
Grafelfing,  DE 82166
Applicant Contact Gordon Dodds
Correspondent
Institut Straumann AG
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact Jennifer M Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Date Received12/29/2017
Decision Date 07/17/2018
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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