Zentek Medical, LLC 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
Bonafix Implant Abutments510(k)Oct 15, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 15, 2025
Bonafix TiBase510(k)Jul 14, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 14, 2023
Bonafix 2 Plus510(k)Dec 20, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 20, 2022