Manufacturer registered with FDA
B.t.i. Biotechnology
MIÑANO, Spain. Lists 19 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 19
- Brands and models
- 1
- 510(k) clearances
- 142003–2024
- Markets registered in
- 12361 registrations outside the US
- Establishments
- 1Spain
510(k) clearances per year, 2000–2026
Registered in 12 markets
Where regulators' registries name B.t.i. Biotechnology as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | B.t.i. Biotechnology | 14 clearances | 2003–2024 | Below |
| Canada | Health Canada | Registration holder | B.T.I. BIOTECHNOLOGY INSTITUTE S.L. | 219 | 2011–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | B.T.I. Biotechnology Institute S.L.BTI Biotechnology Institute S.L. | 47 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | B.T.I. Biotechnology Institute S.L. | 37 | 2021–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | B.T.I. Biotechnology Institute, S.L. | 29 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | B.T.I. BIOTECHNOLOGY INSTITUTE S.L.BTI BIOTECHNOLOGY INSTITUTE, S.L. · B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. | 11 | 2006–2021 | Pure Global AI |
| Colombia | INVIMA | Registration holder | B.T.I. BIOTECHNOLOGY INSTITUTE S.L. | 6 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | B.T.I. Biotechnology Institute S.L.B.T.I. BIOTECHNOLOGY INSTITUTE S.L. · B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. · +1 | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | BTI Biotechnology Institute SL | 4 | 2016–2018 | Pure Global AI |
| Egypt | EDA | Manufacturer | B.T.I. Biotechnology Institute S.L., | 1 | 2025–2025 | Pure Global AI |
| Japan | PMDA | Registration holder | Ｂ．Ｔ． Ｉ． Ｂｉｏｔｅｃｈｎｏｌｏｇｙ Ｉｎｓｔｉｔｕｔｅ， Ｓ．Ｌ． | 1 | 2023–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BTI BIOTECHNOLOGY INSTITUTE S.L. | 1 | 2024–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What B.t.i. Biotechnology currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names B.t.i. Biotechnology as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Oct 2024 | K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | DZE Root-Form Endosseous Implant |
| 8 Dec 2023 | K232750 | BTI Interna Prosthetic Components | NHA Endosseous Dental Implant Abutment |
| 15 Sep 2023 | K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments | NHA Endosseous Dental Implant Abutment |
| 20 Oct 2022 | K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | NHA Endosseous Dental Implant Abutment |
| 21 Jul 2022 | K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | DZE Root-Form Endosseous Implant |
| 29 Jul 2021 | K202825 | BTI Extra-Short Dental Implant System UnicCa | DZE Root-Form Endosseous Implant |
| 17 Aug 2018 | K173257 | BTI Dental Implant System UnicCa | DZE Root-Form Endosseous Implant |
| 2 May 2016 | K151391 | BTI Dental Implant System UnicCa | DZE Root-Form Endosseous Implant |
| 22 Jan 2010 | K091387 | BTI DENTAL IMPLANT 5.5-6.5 | DZE Root-Form Endosseous Implant |
| 6 Oct 2009 | K092112 | BTI DENTAL IMPLANT TINY 2.5-3.0 | DZE Root-Form Endosseous Implant |
| 21 Jun 2007 | K070533 | BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 3 Aug 2006 | K061383 | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | EJL Dental Bur |
| 14 Mar 2006 | K053355 | BTI INTERNA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 11 Sep 2003 | K022258 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
Also lists devices cleared under other names
B.t.i. Biotechnology lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Zest Anchors, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Dec 2007 | K072878 | MODIFICATION TO: LOCATOR IMPLANT ANCHOR | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.FDA reg. 3004417597 | Miñano Alava, Spain | Foreign exporter, Manufacturer, Specification developer |
Other names on FDA records
B.T.I. Biotechnology Institute, S.L.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052086). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.