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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
6 0 Minuteman Rd.
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
Predetermined Change
Control Plan Authorized		 No
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