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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bone grafting material, animal source
510(k) Number K173594
Device Name Straumann cerabone
Institut Straumann AG
Peter Merian Weg 12
Basel,  CH CH-4002
Applicant Contact Christelle Gerspach-Gasser
Straumann USA, LLC
60 Minuteman Road
Andover,  MA  01801
Correspondent Contact Jennifer M. Jackson
Regulation Number872.3930
Classification Product Code
Date Received11/21/2017
Decision Date 10/19/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No