BioHorizons Implant Systems, Inc. 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
BioHorizons CEREC Compatible Ti-Bases510(k)Jun 26, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 26, 2026
Conical Ti Base abutments510(k)May 1, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	May 1, 2025
SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment510(k)Jul 30, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 30, 2024
Tapered Pro Conical Implant System510(k)Jun 5, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jun 5, 2024
MRI compatibility for existing BioHorizons dental implants and abutments510(k)Oct 13, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 13, 2023
Multi-unit Abutments for CONELOG510(k)Mar 16, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 16, 2021