Bicon, Inc.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Bicon, Inc.” (first 1997, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 96 days. 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 | 1 | 109 |
| 2015 | 1 | 172 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 14 | 14 |
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
Review panels
- Dental (18)
Most recent Bicon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143524 | Fiber Disks and Blocks (TRINIA) | EBF | 2015-06-02 | 172 |
| K133608 | TRINIA | EBF | 2014-03-14 | 109 |
| K101849 | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT | DZE | 2010-10-01 | 92 |
| K092035 | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION | DZE | 2009-10-15 | 101 |
| K073368 | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT | DZE | 2008-10-10 | 315 |
| K062044 | THE 5.0 X 6.0MM DENTAL IMPLANT | DZE | 2006-11-21 | 125 |
| K051091 | SYNTHOGRAFT | LYC | 2005-09-01 | 126 |
| K050712 | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT | DZE | 2005-04-22 | 36 |
| K050408 | BICON ORTHODONTIC IMPLANT SYSTEM | DZE | 2005-04-07 | 49 |
| K031568 | BICONITE SURFACE TREATMENT | DZE | 2004-11-23 | 553 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bicon, Inc..
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 Bicon, Inc.?
FDA lists 18 510(k) clearances under the applicant name “Bicon, Inc.” (first 1997, latest 2015), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bicon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bicon, Inc. is 96 days.
Which FDA product codes appear under Bicon, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 14); EBF (Material, Tooth Shade, Resin, 2); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 18 Bicon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Bicon, Inc.'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.