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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K241170
Device Name Dynamic TiBase; TRI Screws
Applicant
Talladium España, SL
Virginia Woolf, 17
Lleida,  ES 25005
Applicant Contact Xavier Soca Filella
Correspondent
Paxmed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/26/2024
Decision Date 10/21/2024
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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