Medical Device Manufacturer · US , South Bend , IN

Heraeus Kulzer, LLC, Mitsui Chemicals Group - FDA 510(k) Cleared Devi...

2 submissions · 2 cleared · Since 2015

Recent clearances: Charisma, iBond Universal & iBond Ceramic Primer

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Heraeus Kulzer, LLC, Mitsui Chemicals Group Dental ✕

2 devices

1-2 of 2

Cleared Nov 15, 2016

Cleared Jul 07, 2015

iBond Universal & iBond Ceramic Primer

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 22, 2026