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FDA 510(k) Application Details - K152830
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K152830
Device Name
Unit, Operative Dental
Applicant
OSSTEM IMPLANT CO.,LTD.
1ST FLOOR, B-DONG, 135 GASAN DIGITAL 2-RO, GEUMCHEON-GU
SEOUL 153-759 KR
Other 510(k) Applications for this Company
Contact
BYEUNGHUN KIM
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2015
Decision Date
04/20/2017
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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