I-GEN— 510(k) K131289

Substantially Equivalent

Megagen Implant Co., Ltd.

FDA 510(k) clearance K131289 for I-GEN, Substantially Equivalent on 2013-09-25. Applicant: Megagen Implant Co., Ltd..

Clearance details

Applicant: Megagen Implant Co., Ltd.
Product code: Code JEY
Advisory panel: Dental
Date received: 2013-05-06
Decision date: 2013-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JEY

product code JEY

Injury: 1,542
Malfunction: 2,292
Total: 3,834

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.