Medical Device Manufacturer · ES , 01510 Minano (Alava)

B.T.I. Biotechnology Institute, Sl. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 2003

Recent clearances: BTI Interna 3.0 Dental Implant System UnicCa®, BTI Interna Prosthetic Components, BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

15
Total
15
Cleared
0
Denied

FDA 510(k) Regulatory Record - B.T.I. Biotechnology Institute, Sl. Dental ✕

14 devices
1-14 of 14
Cleared Oct 10, 2024
BTI Interna 3.0 Dental Implant System UnicCa®
K240262 · DZE
Dental · 253d
Cleared Dec 08, 2023
BTI Interna Prosthetic Components
K232750 · NHA
Dental · 91d
Cleared Sep 15, 2023
BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
K231827 · NHA
Dental · 86d
Cleared Oct 20, 2022
BTI Interna Dental Implant System UnicCa - Prosthetic Components
K213106 · NHA
Dental · 391d
Cleared Jul 21, 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa
K211952 · DZE
Dental · 393d
Cleared Jul 29, 2021
BTI Extra-Short Dental Implant System UnicCa
K202825 · DZE
Dental · 308d
Cleared Aug 17, 2018
BTI Dental Implant System UnicCa
K173257 · DZE
Dental · 311d
Cleared May 02, 2016
BTI Dental Implant System UnicCa
K151391 · DZE
Dental · 342d
Cleared Jan 22, 2010
BTI DENTAL IMPLANT 5.5-6.5
K091387 · DZE
Dental · 256d
Cleared Oct 06, 2009
BTI DENTAL IMPLANT TINY 2.5-3.0
K092112 · DZE
Dental · 84d
Cleared Jun 21, 2007
BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS
K070533 · NHA
Dental · 115d
Cleared Aug 03, 2006
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
K061383 · EJL
Dental · 77d
Cleared Mar 14, 2006
BTI INTERNA DENTAL IMPLANT SYSTEM
K053355 · DZE
Dental · 102d
Cleared Sep 11, 2003
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM
K022258 · DZE
Dental · 426d
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