Vericom Co., Ltd.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Vericom Co., Ltd.” (first 2004, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 59 days. Since 2017 the median was 152 days, against 115 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 | 1 | 122 |
| 2015 | 1 | 88 |
| 2016 | 2 | 356 |
| 2017 | 2 | 186 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 269 |
| 2021 | 1 | 197 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 58 |
| 2026 | 1 | 60 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vericom Co., Ltd. took a median 152 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| ELW | Material, Impression | 5 | 5 |
| KIF | Resin, Root Canal Filling | 4 | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
| LBH | Varnish, Cavity | 1 | 1 |
Review panels
- Dental (20)
Most recent Vericom Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260805 | Dual Core | EBF | 2026-05-11 | 60 |
| K252285 | Well-Root PT | KIF | 2025-09-19 | 58 |
| K203672 | MAZIC Claro CAD and MAZIC Claro Press | EIH | 2021-07-01 | 197 |
| K193260 | U-Cem Premium & MAZIC Cem | EMA | 2020-08-21 | 269 |
| K170950 | Well-Root ST | KIF | 2017-12-20 | 264 |
| K163346 | MAZIC Duro | EBF | 2017-03-17 | 108 |
| K160377 | V-varnish Premium | LBH | 2016-12-02 | 296 |
| K152615 | Vonflex S | ELW | 2016-11-03 | 416 |
| K152518 | Vonflex S Putty | ELW | 2015-11-30 | 88 |
| K140966 | VONFLEX S BITE | ELW | 2014-08-15 | 122 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vericom Co., Ltd..
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 Vericom Co., Ltd.?
FDA lists 20 510(k) clearances under the applicant name “Vericom Co., Ltd.” (first 2004, latest 2026), across 8 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 Vericom Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vericom Co., Ltd. is 59 days. Since 2017: 152 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vericom Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 6); ELW (Material, Impression, 5); KIF (Resin, Root Canal Filling, 4).
Next steps
- See all 20 Vericom Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Vericom Co., Ltd.'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.