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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cleanser, root canal
510(k) Number K162311
Device Name Straumann PrefGel
Applicant
INSTITUT STRAUMANN AG
PETER MERIAN WEG 12
BASEL,  CH CH-4002
Applicant Contact CHRISTOPHER KLACZYK
Correspondent
STRAUMANN USA, LLC
60 MINUTEMAN ROAD
ANDOVER,  MA  01810
Correspondent Contact JENNIFER M. JACKSON
Classification Product Code
KJJ  
Date Received08/18/2016
Decision Date 03/07/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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