Orca Dental AI , Ltd. FDA Approvals

0 new drug approvals and 2 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
CEPHX3D510(k)Mar 5, 2026Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 5, 2026
CEPHX- Cephalometric Analysis Software510(k)Jan 31, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 31, 2024