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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 K250833
Device Name SwissMembrane X; SwissMembrane X Socket
Applicant
Geistlich Pharma AG
Bahnhofstrasse 40
Wolhusen,  CH 6110
Applicant Contact Erik Wirth
Correspondent
Telos Partners, LLC
2850 Frontier Dr.
Warsaw,  IN  46582
Correspondent Contact Roshana Ahmed
Regulation Number872.3930
Classification Product Code
NPL  
Date Received03/19/2025
Decision Date 04/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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