Neocis, Inc. FDA Approvals

0 new drug approvals and 8 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
Yomi S Robotic System510(k)Oct 28, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 28, 2025
Yomi Robotic System510(k)Oct 10, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 10, 2025
Yomi Robotic System510(k)Aug 14, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 14, 2023
Yomi Robotic System510(k)Dec 8, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 8, 2022
Yomi Robotic System510(k)Nov 4, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 4, 2022
Yomi Robotic System with YomiPlan Go510(k)Jun 14, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 14, 2022
Neocis Guidance System (NGS) with Yomi Plan v2.0.1510(k)Dec 22, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 22, 2021
Neocis Guidance System (NGS) with Intraoral Fiducial Array510(k)Jul 28, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 28, 2021