Innovative Bioceramix, Inc. FDA Approvals

0 new drug approvals and 2 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
iRoot SP Plus510(k)May 31, 2023Dental	Dental	510(k)Substantially Equivalent (Special)	May 31, 2023
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material510(k)Nov 22, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 22, 2022