Envisiontec GmbH FDA Approvals

0 new drug approvals and 4 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
SmileGuard510(k)Jun 10, 2022	—	510(k)Substantially Equivalent (Traditional)	Jun 10, 2022
E-Temp510(k)Jun 14, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 14, 2021
E-Dent 1000510(k)May 25, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 25, 2021
E-Denture Pro510(k)Mar 30, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 30, 2021