Fona S.R.L 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
FONA XDC510(k)Aug 23, 2022Dental	Dental	510(k)Substantially Equivalent (Special)	Aug 23, 2022
Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph510(k)Mar 2, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 2, 2022
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2510(k)Aug 30, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 30, 2021