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FDA 510(k) Application Details - K210041
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K210041
Device Name
Material, Impression
Applicant
Osstem Implant Co., Ltd.
66-16, Bansong-ro 513beon-gil, Haeundae-gu
Busan 48002 KR
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Contact
Jinwoo Bae
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2021
Decision Date
03/18/2021
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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