B.T.I. Biotechnology Institute, Sl. 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
BTI Interna 3.0 Dental Implant System UnicCa®510(k)Oct 10, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 10, 2024
BTI Interna Prosthetic Components510(k)Dec 8, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 8, 2023
BTI Dental Implant System UnicCa® Aesthetic Post Abutments510(k)Sep 15, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 15, 2023
BTI Interna Dental Implant System UnicCa - Prosthetic Components510(k)Oct 20, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 20, 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa510(k)Jul 21, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 21, 2022
BTI Extra-Short Dental Implant System UnicCa510(k)Jul 29, 2021Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jul 29, 2021