FDA 510(k) Application Details - K162021

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K162021
Device Name Abutment, Implant, Dental, Endosseous
Applicant TALLADIUM ESPANA, SL
PLAZA UTXESA 7
LLEIDA 25002 ES
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Contact ESTEBAN XAM-MAR
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 07/21/2016
Decision Date 05/04/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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