I-Gen
i-Gen is a preformed titanium membrane that stabilizes and supports bone grafts in dentoalveolar defects. It is used as a bone plate within oral graft reconstruction. The noncoated membrane…
i-Gen is a preformed titanium membrane that stabilizes and supports bone grafts in dentoalveolar defects. It is used as a bone plate within oral graft reconstruction. The noncoated membrane is made from commercially pure Grade 2 titanium.
The range offers different shapes and small, regular or wide configurations for the defect location. Buccal widths range from 9 to 22 mm, with lengths including 11, 15, 16 and 17.5 mm. The clinician selects the configuration for the defect’s size and shape.
Listed Item
i-Gen Type A2
Supply and Graft Role
The devices are supplied sterile for single use and disposal, with a stated shelf life of five years. Their role is supporting the bone graft at the defect site rather than replacing a missing tooth or serving as an implant abutment.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | Megagen Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K131289 |
| Record published | 2015-06-25 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IG1W5510 | In distribution | |
| IG1W4509 | In distribution | |
| IG3W0921 | In distribution | |
| IGM1725 | In distribution | |
| IG2W0918 | In distribution | |
| IG2W1323 | In distribution | |
| IGM2229 | In distribution | |
| IGM1522 | In distribution | |
| IG2W1120 | In distribution | |
| IG1W6511 | In distribution | |
| IG3W1125 | In distribution | |
| IG3W1328 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131289 | 2013-09-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.