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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 K242817
Device Name Jason membrane
Applicant
Botiss Biomaterials GmbH
Hauptstrasse 28
Zossen,  DE 15806
Applicant Contact Thomas Unsoeld
Correspondent
Botiss Biomaterials GmbH
Hauptstrasse 28
Zossen,  DE 15806
Correspondent Contact Elena Pies
Regulation Number872.3930
Classification Product Code
NPL  
Date Received09/18/2024
Decision Date 12/12/2025
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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