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FDA 510(k) Application Details - K192347
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K192347
Device Name
Implant, Endosseous, Root-Form
Applicant
Megagen Implant Co. Ltd
45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
Daegu 42921 KR
Other 510(k) Applications for this Company
Contact
You Jung Kim
Other 510(k) Applications for this Contact
Regulation Number
872.3640
More FDA Info for this Regulation Number
Classification Product Code
DZE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/29/2019
Decision Date
11/14/2019
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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