Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Tokuyama Dental Corporation · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
288 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | 2021-05-25 | 153 | 0 |
| K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | 2021-02-03 | 56 | 0 |
| K193537 | Omnichroma Flow | Tokuyama Dental Corporation | 2020-08-19 | 243 | 0 |
| K190940 | Tokuyama Rebase III | Tokuyama Dental Corporation | 2019-10-04 | 177 | 0 |
| K180613 | Estelite Universal Flow | Tokuyama Dental Corporation | 2018-07-12 | 126 | 0 |
| K173275 | OMNICHROMA | Tokuyama Dental Corporation | 2018-02-27 | 138 | 0 |
| K171226 | TOKUYAMA UNIVERSAL BOND | Tokuyama Dental Corporation | 2017-11-28 | 216 | 0 |
| K170549 | TOKUYAMA CUREGRACE | Tokuyama Dental Corporation | 2017-07-05 | 131 | 0 |
| K161353 | ESTELITE BULK FILL Flow | Tokuyama Dental Corporation | 2017-04-03 | 322 | 0 |
| K150727 | ESTECEM | Tokuyama Dental Corporation | 2015-06-17 | 89 | 0 |
| K112445 | SOFRELINER TOUGH S | Tokuyama Dental Corporation | 2011-10-28 | 65 | 0 |
| K110178 | ESTELITE COLOR | Tokuyama Dental Corporation | 2011-04-05 | 74 | 0 |
| K100172 | TOKUYAMA SHIELD FORCE | Tokuyama Dental Corporation | 2010-10-21 | 273 | 0 |
| K081554 | TOKUYAMA TISSUECARE | Tokuyama Dental Corporation | 2009-03-18 | 288 | 0 |
| K080940 | ESTELITE SIGMA QUICK | Tokuyama Dental Corporation | 2008-06-19 | 77 | 0 |
| K072746 | E-1 ESTHETIC COMPOSITE SYSTEM | Tokuyama Dental Corporation | 2007-12-04 | 68 | 0 |
| K070215 | TOKUYAMA BOND FORCE | Tokuyama Dental Corporation | 2007-03-30 | 66 | 0 |
| K051808 | ESTELITE FLOW QUICK | Tokuyama Dental Corporation | 2005-08-08 | 34 | 0 |
| K030663 | TOKUYAMA SOFRELINER TOUGH | Tokuyama Dental Corporation | 2003-05-29 | 87 | 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