Medical Device Manufacturer · US , Los Angeles , CA

Nibec Co., Ltd. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2014

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nibec Co., Ltd. Dental ✕

3 devices

1-3 of 3

Cleared Dec 10, 2015

Regenomer® Syringe, Regenomer® Plug, Regenomer® Block

Cleared Jul 31, 2015

Cleared Nov 05, 2014

Data Source

Sourced from the FDA 510(k) public files . 175,730 total devices indexed.

Last updated: Apr 28, 2026