Kulzer, LLC FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One510(k)Mar 11, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 11, 2026
iCEM Universal Plus510(k)Dec 19, 2025Dental	Dental	510(k)Substantially Equivalent (Abbreviated)	Dec 19, 2025
Retraxil510(k)Sep 24, 2025	—	510(k)Substantially Equivalent (Traditional)	Sep 24, 2025
Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active510(k)Sep 17, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 17, 2024
dima Print Teeth & Temp510(k)May 23, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 23, 2024
Signum opaque F510(k)Sep 7, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 7, 2023
Venus Bulk Flow ONE510(k)Apr 21, 2022Dental	Dental	510(k)Substantially Equivalent (Special)	Apr 21, 2022