Detax GmbH 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
Freeprint® denture flex510(k)Oct 30, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 30, 2025
FREEPRINT® splintmaster510(k)Oct 12, 2023	—	510(k)Substantially Equivalent (Traditional)	Oct 12, 2023
FREEPRINT crown510(k)Sep 23, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 23, 2022