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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Animal Source, Intraoral
510(k) Number K251062
Device Name Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Marco Steiner
Correspondent
Telos Partners, LLC
2458 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
NPL  
Subsequent Product Code
NPM  
Date Received04/04/2025
Decision Date 08/14/2025
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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