Kulzer, LLC - FDA 510(k) Cleared Devices
Recent clearances: Venus Diamond, iCEM Universal Plus, Retraxil
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kulzer, LLC Dental ✕
7 devices
Cleared
Mar 11, 2026
Venus Diamond
Dental
1d
Cleared
Dec 19, 2025
iCEM Universal Plus
Dental
2d
Cleared
Sep 24, 2025
Retraxil
Dental
279d
Cleared
Sep 17, 2024
Signum composite flow
Dental
193d
Cleared
May 23, 2024
dima Print Teeth & Temp
Dental
169d
Cleared
Sep 07, 2023
Signum opaque F
Dental
183d
Cleared
Apr 21, 2022
Venus Bulk Flow ONE
Dental
50d