Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bicon, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
109 daysmedian FDA review time
315 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K143524 | Fiber Disks and Blocks (TRINIA) | Bicon, LLC | 2015-06-02 | 172 | 0 |
| K133608 | TRINIA | Bicon, LLC | 2014-03-14 | 109 | 0 |
| K101849 | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT | Bicon, LLC | 2010-10-01 | 92 | 0 |
| K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION | Bicon, LLC | 2009-10-15 | 101 | 0 |
| K073368 | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT | Bicon, LLC | 2008-10-10 | 315 | 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