Biomet 3i, LLC FDA Approvals

0 new drug approvals and 6 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
T3 Pro Implants ZimVie Packaging System510(k)Jun 27, 2025Dental	Dental	510(k)Substantially Equivalent (Special)	Jun 27, 2025
Immediate Molar Implants510(k)Oct 23, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 23, 2024
BellaTek Bars510(k)Jul 15, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 15, 2024
TSX Implants510(k)Sep 14, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 14, 2022
T3 Pro Implants510(k)Mar 28, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 28, 2022
BellaTek Encode Emergence Healing Abutments510(k)Dec 21, 2021Dental	Dental	510(k)Substantially Equivalent (Special)	Dec 21, 2021