Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K190637 |
Device Name |
Fit & Brilliant Dental Implant System |
Applicant |
F&B Technology Co., Ltd. |
17-230, #37, Kwaegam-ro, Sasang-ku, |
(Kwaebop, Ind. Supplies Market) |
Busan,
KR
46977
|
|
Applicant Contact |
J H An |
Correspondent |
Onbix Corporation |
#821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu |
Seoul,
KR
46977
|
|
Correspondent Contact |
Ho Dong Yang |
Regulation Number | 872.3640
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/12/2019 |
Decision Date | 06/19/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|