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FDA 510(k) Application Details - K112045
Device Classification Name
Abutment, Implant, Dental, Endosseous
More FDA Info for this Device
510(K) Number
K112045
Device Name
Abutment, Implant, Dental, Endosseous
Applicant
DENTIUM CO., LTD.
27-5 LEUI-DONG, YEONGTONG-GU
SUWON-SI, GYEONGGI-DO 442-270 KR
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Contact
JONGHYUN CHOI
Other 510(k) Applications for this Contact
Regulation Number
872.3630
More FDA Info for this Regulation Number
Classification Product Code
NHA
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More FDA Info for this Product Code
Date Received
07/18/2011
Decision Date
01/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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