Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
B.T.I. Biotechnology Institute, Sl. · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
253 daysmedian FDA review time
393 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | B.T.I. Biotechnology Institute, Sl. | 2024-10-10 | 253 | 0 |
| K232750 | BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | 2023-12-08 | 91 | 0 |
| K231827 | BTI Dental Implant System UnicCa® – Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | 2023-09-15 | 86 | 0 |
| K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Compon | B.T.I. Biotechnology Institute, Sl. | 2022-10-20 | 391 | 0 |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2022-07-21 | 393 | 0 |
| K202825 | BTI Extra-Short Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2021-07-29 | 308 | 0 |
| K173257 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2018-08-17 | 311 | 0 |
| K151391 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | 2016-05-02 | 342 | 0 |
| K091387 | BTI DENTAL IMPLANT 5.5-6.5 | B.T.I. Biotechnology Institute, Sl. | 2010-01-22 | 256 | 0 |
| K092112 | BTI DENTAL IMPLANT TINY 2.5-3.0 | B.T.I. Biotechnology Institute, Sl. | 2009-10-06 | 84 | 0 |
| K070533 | BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS | B.T.I. Biotechnology Institute, Sl. | 2007-06-21 | 115 | 0 |
| K061383 | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | B.T.I. Biotechnology Institute, Sl. | 2006-08-03 | 77 | 0 |
| K053355 | BTI INTERNA DENTAL IMPLANT SYSTEM | B.T.I. Biotechnology Institute, Sl. | 2006-03-14 | 102 | 0 |
| K051392 | BTI-SCAN, VERSION 4.0 | B.T.I. Biotechnology Institute, Sl. | 2005-06-29 | 33 | 0 |
| K022258 | B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEM | B.T.I. Biotechnology Institute, Sl. | 2003-09-11 | 426 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda