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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 K192742
Device Name Straumann Variobase C
Applicant
Institut Straumann AG
Lochhamer Schlag 6
Grafelfing,  DE 82166
Applicant Contact Gordon Dodds
Correspondent
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
PNP  
Date Received09/30/2019
Decision Date 02/12/2021
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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