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FDA 510(k) Application Details - K162021
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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