K182759 is an FDA 510(k) clearance for the BoniPlus Dental G-Mesh System. This device is classified as a Plate, Bone (Class II - Special Controls, product code JEY).
Submitted by Montjade Engineering Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on July 29, 2020, 670 days after receiving the submission on September 28, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.
| 510(k) Number | K182759 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2018 |
| Decision Date | July 29, 2020 |
| Days to Decision | 670 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | JEY - Plate, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4760 |