I-Gen
510(k) K131289
I-Gen is a Class II device made by Megagen Implant Co., Ltd., cleared under FDA 510(k) K131289 on 25 Sep 2013, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131289 | Date25 Sep 2013 | StatusActive |
Official records
- FDA 510(k) database K131289
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JEY
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K131289
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| i-Gen IG1W4509 | IG1W4509 / IG1W4509 | 08806388221660 | — | On the market |
| i-Gen IG1W5510 | IG1W5510 / IG1W5510 | 08806388221677 | — | On the market |
| i-Gen IG1W6511 | IG1W6511 / IG1W6511 | 08806388221684 | — | On the market |
| i-Gen IG2W0918 | IG2W0918 / IG2W0918 | 08806388221691 | — | On the market |
| i-Gen IG2W1120 | IG2W1120 / IG2W1120 | 08806388221707 | — | On the market |
| i-Gen IG2W1323 | IG2W1323 / IG2W1323 | 08806388221714 | — | On the market |
| i-Gen IG3W0921 | IG3W0921 / IG3W0921 | 08806388221721 | — | On the market |
| i-Gen IG3W1125 | IG3W1125 / IG3W1125 | 08806388221738 | — | On the market |
| i-Gen IG3W1328 | IG3W1328 / IG3W1328 | 08806388221745 | — | On the market |
| i-Gen IGM1522 | IGM1522 / IGM1522 | 08806388221752 | — | On the market |
| i-Gen IGM1725 | IGM1725 / IGM1725 | 08806388221769 | — | On the market |
| i-Gen IGM2229 | IGM2229 / IGM2229 | 08806388221776 | — | On the market |
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