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FDA 510(k) Application Details - K160965
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K160965
Device Name
Implant, Endosseous, Root-Form
Applicant
DENTIUM CO., LTD.
29 TEHERAN-RO, 87-GZL
GANGNAM-GU
SEOUL 446-518 KR
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Contact
YOUNJUNG YUK
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Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
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More FDA Info for this Product Code
Date Received
04/06/2016
Decision Date
01/13/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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