B.T.I. Biotechnology Institute, Sl.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “B.T.I. Biotechnology Institute, Sl.” (first 2003, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 253 days. Since 2017 the median was 308 days, against 155 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 342 |
| 2017 | 0 | — |
| 2018 | 1 | 311 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 308 |
| 2022 | 2 | 392 |
| 2023 | 2 | 88 |
| 2024 | 1 | 253 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name B.T.I. Biotechnology Institute, Sl. took a median 308 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 9 | 9 |
| NHA | Abutment, Implant, Dental, Endosseous | 4 | 4 |
| EJL | Bur, Dental | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
Most recent B.T.I. Biotechnology Institute, Sl. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | DZE | 2024-10-10 | 253 |
| K232750 | BTI Interna Prosthetic Components | NHA | 2023-12-08 | 91 |
| K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments | NHA | 2023-09-15 | 86 |
| K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | NHA | 2022-10-20 | 391 |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | DZE | 2022-07-21 | 393 |
| K202825 | BTI Extra-Short Dental Implant System UnicCa | DZE | 2021-07-29 | 308 |
| K173257 | BTI Dental Implant System UnicCa | DZE | 2018-08-17 | 311 |
| K151391 | BTI Dental Implant System UnicCa | DZE | 2016-05-02 | 342 |
| K091387 | BTI DENTAL IMPLANT 5.5-6.5 | DZE | 2010-01-22 | 256 |
| K092112 | BTI DENTAL IMPLANT TINY 2.5-3.0 | DZE | 2009-10-06 | 84 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named B.T.I. Biotechnology Institute, Sl..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under B.T.I. Biotechnology Institute, Sl.?
FDA lists 15 510(k) clearances under the applicant name “B.T.I. Biotechnology Institute, Sl.” (first 2003, latest 2024), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by B.T.I. Biotechnology Institute, Sl.?
The median time from FDA receipt to decision across 510(k)s cleared under the name B.T.I. Biotechnology Institute, Sl. is 253 days. Since 2017: 308 days, versus 155 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under B.T.I. Biotechnology Institute, Sl.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 9); NHA (Abutment, Implant, Dental, Endosseous, 4); EJL (Bur, Dental, 1).
Next steps
- See all 15 B.T.I. Biotechnology Institute, Sl. clearances with predicates and recalls
- Run predicate analysis for product code DZE, B.T.I. Biotechnology Institute, Sl.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.