# K182759: BoniPlus Dental G-Mesh System

- Pathway: 510(k) (Traditional)
- Applicant: Montjade Engineering Co., Ltd.
- Decided: Jul 29, 2020 after 670 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K894595 (1990). 111 ancestors in all.
No later device cites it as a predicate yet.
0 of 112 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111761: Neo Titanium Mesh, Cti-Mem, Neobiotech Co., Ltd. (2012) Summary page 4.
- K120951: Smartbuilder System, Osstem Implant Co., Ltd. (2012) Summary page 5.
- K151540: MC BIO Supertack Tack 3mm, 4mm and 5mm, Eli-Ka Technologies (2016) Summary page 5.
- K170697: GBR system, Surgident (2018) Summary page 5.

## Indications for use
“BoniPlus” Dental G-Mesh System is the non-absorbable membrane that is made of titanium metal to stabilize and support bone grafts in dento-alveolar bony defect sites.

Source page: https://510kreport.com/device/K182759
Methodology: https://510kreport.com/methodology