# B.T.I. Biotechnology Institute, Sl.

- Location (FDA's records): Minano, ES
- FDA decisions: 15 (2003–2024): 15 510(k) clearances
- Product codes: DZE (9), NHA (4), LLZ (1), EJL (1)
- 510(k) review time since 2016: median 310 days, against 191 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 33 (24 its own); citations of its devices by later devices: 26 (24 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Astra Tech, Inc.: 2 (https://510kreport.com/company/astra-tech)
- Biomet 3i, Inc.: 1 (https://510kreport.com/company/biomet-3i)
- S.I.N. - Sistema DE Implante Nacional S.A.: 1 (https://510kreport.com/company/sin-sistema-de-implante-nacional)
- BioHorizons Implant Systems, Inc.: 1 (https://510kreport.com/company/biohorizons-implant-systems)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Straumann USA: 1 (https://510kreport.com/company/straumann-usa)
- Implant Innovations, Inc.: 1 (https://510kreport.com/company/implant-innovations)
- Materialise NV: 1 (https://510kreport.com/company/materialise)

## Firms that cite its devices most
- Talladium España, SL: 1 (https://510kreport.com/company/talladium-espana)
- Mozograu S.A.: 1 (https://510kreport.com/company/mozograu)

## Its most-cited devices
- K022258: B.T.I. Biotechnology Institute, S.L. Dental Implant System (2003), cited by 7
- K053355: Bti Interna Dental Implant System (2006), cited by 7
- K151391: BTI Dental Implant System UnicCa (2016), cited by 4
- K231827: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments (2023), cited by 2
- K213106: BTI Interna Dental Implant System UnicCa - Prosthetic Components (2022), cited by 2
- K211952: BTI Interna Narrow/Plus Dental Implant System UnicCa (2022), cited by 1

## Recent decisions
- K240262: BTI Interna 3.0 Dental Implant System UnicCa® (Oct 10, 2024)
- K232750: BTI Interna Prosthetic Components (Dec 8, 2023)
- K231827: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments (Sep 15, 2023)
- K213106: BTI Interna Dental Implant System UnicCa - Prosthetic Components (Oct 20, 2022)
- K211952: BTI Interna Narrow/Plus Dental Implant System UnicCa (Jul 21, 2022)
- K202825: BTI Extra-Short Dental Implant System UnicCa (Jul 29, 2021)
- K173257: BTI Dental Implant System UnicCa (Aug 17, 2018)
- K151391: BTI Dental Implant System UnicCa (May 2, 2016)

Source page: https://510kreport.com/company/bti-biotechnology-institute