Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vericom Co., Ltd. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
296 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 | 60 | 0 |
| K252285 | Well-Root PT | Vericom Co., Ltd. | 2025-09-19 | 58 | 0 |
| K203672 | MAZIC Claro CAD and MAZIC Claro Press | Vericom Co., Ltd. | 2021-07-01 | 197 | 0 |
| K193260 | U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. | 2020-08-21 | 269 | 0 |
| K170950 | Well-Root ST | Vericom Co., Ltd. | 2017-12-20 | 264 | 0 |
| K163346 | MAZIC Duro | Vericom Co., Ltd. | 2017-03-17 | 108 | 0 |
| K160377 | V-varnish Premium | Vericom Co., Ltd. | 2016-12-02 | 296 | 0 |
| K152615 | Vonflex S | Vericom Co., Ltd. | 2016-11-03 | 416 | 0 |
| K152518 | Vonflex S Putty | Vericom Co., Ltd. | 2015-11-30 | 88 | 0 |
| K140966 | VONFLEX S BITE | Vericom Co., Ltd. | 2014-08-15 | 122 | 0 |
| K103164 | VONFLEX HEAVY, VINFLEX LIGHT | Vericom Co., Ltd. | 2010-11-10 | 14 | 0 |
| K103121 | ECO-S | Vericom Co., Ltd. | 2010-10-26 | 4 | 0 |
| K091267 | VONFLEX PUTTY | Vericom Co., Ltd. | 2009-05-06 | 6 | 0 |
| K090992 | WELL-PASTE | Vericom Co., Ltd. | 2009-04-21 | 14 | 0 |
| K080266 | WELL-PEX | Vericom Co., Ltd. | 2008-02-06 | 5 | 0 |
| K080265 | DENFIL ETCHANT-37 | Vericom Co., Ltd. | 2008-02-06 | 5 | 0 |
| K072069 | SPACER | Vericom Co., Ltd. | 2007-09-28 | 60 | 0 |
| K060637 | DENFIL FLOW | Vericom Co., Ltd. | 2006-03-16 | 6 | 0 |
| K043562 | BC PLUS | Vericom Co., Ltd. | 2005-01-03 | 7 | 0 |
| K042124 | DENFIL | Vericom Co., Ltd. | 2004-08-13 | 7 | 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