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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 K162021
Device Name 3.0 Dynamic TiBase
Applicant
TALLADIUM ESPANA, SL
PLAZA UTXESA 7
LLEIDA,  ES 25002
Applicant Contact ESTEBAN XAM-MAR
Correspondent
LUIZ GALDINO
28102 Alton Way
Castaic,  CA  91384
Correspondent Contact Luiz Galdino
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/21/2016
Decision Date 05/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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