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FDA 510(k) Application Details - K181236
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K181236
Device Name
Material, Impression
Applicant
OSSTEM IMPLANT CO LTD
203, GEOJE-DAERO YEONJE-GU
BUSAN 611-804 KR
Other 510(k) Applications for this Company
Contact
Jungmin Yoo
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
05/10/2018
Decision Date
09/13/2018
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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