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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 K240661
Device Name Geistlich Bio-Oss®
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Marco Steiner
Correspondent
Telos Partners, LLC
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
NPM  
Subsequent Product Code
MQV  
Date Received03/08/2024
Decision Date 07/12/2024
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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