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FDA 510(k) Application Details - K210789
Device Classification Name
Locator, Root Apex
More FDA Info for this Device
510(K) Number
K210789
Device Name
Locator, Root Apex
Applicant
Meta Systems Co., Ltd.
#1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu
Seongnam-si 13229 KR
Other 510(k) Applications for this Company
Contact
Hyejin Park
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/16/2021
Decision Date
10/20/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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