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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 K212463
Device Name Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH CH-6110
Applicant Contact Marco Steiner
Correspondent
Telos Partners, LLC
571 Christina Lake Dr.
Lakeland,  FL  33813
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
NPL  
Subsequent Product Code
NPM  
Date Received08/06/2021
Decision Date 04/05/2022
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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