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FDA 510(k) Application Details - K153639
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K153639
Device Name
Implant, Endosseous, Root-Form
Applicant
DENTIS CO., LTD.
99, SEONGSEOSEO-RO, DALSEO-GU
DAEGU 41718 KR
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Contact
SUN CHUL SHIN
Other 510(k) Applications for this Contact
Regulation Number
872.3640
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Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2015
Decision Date
04/08/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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