Device Classification Name |
plate, bone
|
510(k) Number |
K182759 |
Device Name |
BoniPlus Dental G-Mesh System |
Applicant |
MontJade Engineering Co., Ltd. |
No.2-1, Gongyequ 7th Rd., Xitun Dist. |
Taichung City,
TW
40755
|
|
Applicant Contact |
Yu Sheng Lin |
Correspondent |
MontJade Engineering Co., Ltd. |
No.2-1, Gongyequ 7th Rd., Xitun Dist. |
Taichung City,
TW
40755
|
|
Correspondent Contact |
Yu Sheng Lin |
Regulation Number | 872.4760
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/28/2018 |
Decision Date | 07/29/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|