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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 K252253
Device Name Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Marco Steiner
Correspondent
QUARAS, LLC
2101 Camino Rey
Fullerton,  CA  92833
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
NPL  
Date Received07/21/2025
Decision Date 11/25/2025
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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