Device Classification Name |
Implant, Endosseous, Root-Form
More FDA Info for this Device |
510(K) Number |
K190637 |
Device Name |
Implant, Endosseous, Root-Form |
Applicant |
F&B Technology Co., Ltd.
17-230, #37, Kwaegam-ro, Sasang-ku,
(Kwaebop, Ind. Supplies Market)
Busan 46977 KR
Other 510(k) Applications for this Company
|
Contact |
J H An
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 |
03/12/2019 |
Decision Date |
06/19/2020 |
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 |
|