Dentium Co., Ltd (Ict Branch) FDA Approvals

0 new drug approvals and 3 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
bright CT510(k)Dec 14, 2023Radiology	Radiology	510(k)Substantially Equivalent (Special)	Dec 14, 2023
rainbow MCT510(k)Apr 16, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2021
rainbow CT510(k)Apr 16, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 16, 2021