510(k) · Cleared
ClearedBoniPlus Dental G-Mesh System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Montjade Engineering Co., Ltd. · JEY Plate, Bone
Cleared on Jul 29, 2020 as substantially equivalent to K111761 (Neobiotech Co., Ltd., 2012) and 3 other predicates after a 670-day review. Its family tree reaches back 10 generations to 1990.
- Decided
- Jul 29, 2020
- Review
- 670 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K894595 (1990). 111 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 1 generation backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- This deviceK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 7 generations backK011879 3A Dental Implant SystemOsseco Biosource, Ltd. · 2002
- 6 generations backK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
- 5 generations backK062051 SS SystemOsstem Implant Co., Ltd. · 2006
- 4 generations backK063861 GS SystemOsstem Implant Co., Ltd. · 2007
- 3 generations backK073465 US/GS Ultra Wide SystemOsstem Implant Co., Ltd. · 2008
- 2 generations backK090825 SQ IS SystemNeobiotech Co., Ltd. · 2009
- 1 generation backK120951 Smartbuilder SystemOsstem Implant Co., Ltd. · 2012
- This deviceK182759 BoniPlus Dental G-Mesh SystemMontjade Engineering Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −7 | K011879 | 3A Dental Implant System | Osseco Biosource, Ltd. | 2002 | — |
| −6 | K051576 | Avana Dental Implant System | Osstem Co., Ltd. | 2005 | — |
| −5 | K062051 | SS System | Osstem Implant Co., Ltd. | 2006 | — |
| −4 | K063861 | GS System | Osstem Implant Co., Ltd. | 2007 | — |
| −3 | K073465 | US/GS Ultra Wide System | Osstem Implant Co., Ltd. | 2008 | — |
| −2 | K090825 | SQ IS System | Neobiotech Co., Ltd. | 2009 | — |
| −1 | K120951 | Smartbuilder System | Osstem Implant Co., Ltd. | 2012 | — |
| 0 (this device) | K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1979 | 2 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 10 | 0 |
| 1995 | 4 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111761 | Neo Titanium Mesh, Cti-MemSummary page 4…ation Product Code: JEY Regulation number: 872.4760 Device Class: Ⅱ 510(k) Number: K111761 5.6 Identification of the Reference Device Ⅰ: Predicate Device Name: SMARTbuilder System… | 2012 |
| * | K120951 | Smartbuilder SystemSummary page 5…oduct Code: NHA Regulation number: 872.4760 Device Class: Ⅱ 510(k) Number: K120951 5.7 Identification of the Reference Device Ⅱ: Predicate Device Name: MC BIO “SuperTack” tack 3mm, 4mm… | 2012 |
| * | K151540 | MC BIO Supertack Tack 3mm, 4mm and 5mmSummary page 5…n Product Code: DZL Regulation number: 872.4880 Device Class: Ⅱ 510(k) Number: K151540 5.8 Identification of the Reference Device Ⅲ: Predicate Device Name: GBR System Applicant:… | 2016 |
| * | K170697 | GBR systemSummary page 5…oduct Code: DZL Regulation number: 872.4760 Device Class: Ⅱ 510(k) Number: K170697 5.9 Indications for Use of the Device “BoniPlus” Dental G-Mesh System is the non-absorbable membrane that is made of titanium… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 111 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111761.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
“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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182759 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182759: BoniPlus Dental G-Mesh System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182759
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026