Cosmedent, Inc. 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
Insure® Universal; Insure® Universal Automix510(k)Jul 24, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 24, 2024
Renamel® Microhybrid ;Renamel® Flowable Microhybrid510(k)Oct 11, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 11, 2022
Renamel Bulkfill510(k)Jun 24, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 24, 2021