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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 K212108
Device Name Dynamic TiBase
Applicant
Talladium España, SL
C/ 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 A. Thomas
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
DZE  
Date Received07/06/2021
Decision Date 09/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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