Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bicon, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
553 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062044 | THE 5.0 X 6.0MM DENTAL IMPLANT | Bicon, Inc. | 2006-11-21 | 125 | 0 |
| K051091 | SYNTHOGRAFT | Bicon, Inc. | 2005-09-01 | 126 | 0 |
| K050712 | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT | Bicon, Inc. | 2005-04-22 | 36 | 0 |
| K050408 | BICON ORTHODONTIC IMPLANT SYSTEM | Bicon, Inc. | 2005-04-07 | 49 | 0 |
| K031568 | BICONITE SURFACE TREATMENT | Bicon, Inc. | 2004-11-23 | 553 | 0 |
| K042637 | THE 5.0 X 6.0MM DENTAL IMPLANT | Bicon, Inc. | 2004-11-15 | 49 | 0 |
| K023705 | BICON TRANSITIONAL IMPLANT (BTI) SYSTEM | Bicon, Inc. | 2003-01-29 | 86 | 0 |
| K010185 | 6.0 X 5.7MM DENTAL IMPLANT | Bicon, Inc. | 2002-12-30 | 710 | 0 |
| K994037 | THE 4.5MM DIAMETER BICON DENTAL IMPLANT | Bicon, Inc. | 2000-01-11 | 43 | 0 |
| K982488 | BICON BONE SCREW SYSTEM | Bicon, Inc. | 1999-01-26 | 193 | 0 |
| K973056 | BONE GRAFT SCREW SYSTEM | Bicon, Inc. | 1997-11-12 | 89 | 0 |
| K972417 | THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM | Bicon, Inc. | 1997-09-17 | 82 | 0 |
| K972029 | BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM | Bicon, Inc. | 1997-08-18 | 77 | 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