Micro-Nx Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
ELEC ENGINE (Model: ISE-170L)510(k)Jul 18, 2025Dental	Dental	510(k)Substantially Equivalent (Special)	Jul 18, 2025
Dental Handpiece, Wireless Endodontic Handpiece, endoit510(k)Nov 9, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 9, 2023
Dental Handpiece, Model CA160, CA160L, and CA500L510(k)Jul 29, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 29, 2022
ELEC-LED510(k)Feb 7, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Feb 7, 2022
Impla-NX (Model: ISE-270M)510(k)May 21, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 21, 2021