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FDA 510(k) Application Details - K223924
Device Classification Name
Implant, Endosseous, Root-Form
More FDA Info for this Device
510(K) Number
K223924
Device Name
Implant, Endosseous, Root-Form
Applicant
Ossvis Co., Ltd.
7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu
Anyang-si 14055 KR
Other 510(k) Applications for this Company
Contact
Young Jae 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
12/30/2022
Decision Date
08/08/2023
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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