The following data is part of a premarket notification filed by Montjade Engineering Co., Ltd. with the FDA for Boniplus Dental G-mesh System.
| Device ID | K182759 |
| 510k Number | K182759 |
| Device Name: | BoniPlus Dental G-Mesh System |
| Classification | Plate, Bone |
| Applicant | MontJade Engineering Co., Ltd. No.2-1, Gongyequ 7th Rd., Xitun Dist. Taichung City, TW 40755 |
| Contact | Yu Sheng Lin |
| Correspondent | Yu Sheng Lin MontJade Engineering Co., Ltd. No.2-1, Gongyequ 7th Rd., Xitun Dist. Taichung City, TW 40755 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2020-07-29 |