Pro3Dure Medical 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
Thermeo System510(k)Apr 8, 2022	—	510(k)Substantially Equivalent (Traditional)	Apr 8, 2022
GR Splint Resin System510(k)Oct 21, 2021	—	510(k)Substantially Equivalent (Traditional)	Oct 21, 2021
GR-14 Resin System510(k)May 5, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 5, 2021