i-Gen IGM2229
i-Gen IGM2229 is a Class II device made by Megagen Implant Co. Ltd, cleared under FDA 510(k) K131289 on 25 Sep 2013 and listed in FDA GUDID since 25 Jun 2015 (UDI-DI 08806388221776), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08806388221776 | Date25 Jun 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK131289 | Date25 Sep 2013 | StatusActive |
Official records
- AccessGUDID record 08806388221776
- FDA 510(k) database K131289
Across registries
- FDA 510(k) K131289 decided 25 Sep 2013 Active
- FDA GUDID UDI-DI 08806388221776 listed 25 Jun 2015 Listed
Timeline
- Cleared FDA 510(k) K131289
- Listed FDA GUDID 08806388221776
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- i-Gen
- Generic name
- Dental bone matrix implant, metallic
- Model / Ref / Catalog
- IGM2229
- Description
- i-Gen Type D3
- Primary DI / UDI-DI
- 08806388221776
- 510(k) Number
- FDA product code
- JEY
- GMDN term
- Dental bone matrix implant, metallic
- Device class
- Class II
- Regulation number
- 872.4760
- GUDID distribution status
- In Commercial Distribution
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