Medical Device Manufacturer · US , South Bend , IN

Kulzer, LLC - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2022

7

Total

7

Cleared

0

Denied

FDA 510(k) cleared devices by Kulzer, LLC Dental ✕

7 devices

1-7 of 7

Cleared Mar 11, 2026

Cleared Dec 19, 2025

iCEM Universal Plus

Cleared Sep 24, 2025

Cleared Sep 17, 2024

Signum composite flow

Cleared May 23, 2024

dima Print Teeth & Temp

Cleared Sep 07, 2023

Signum opaque F

Cleared Apr 21, 2022

Venus Bulk Flow ONE