Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Kuraray America, Inc. · Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
94 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111982 | CLEARFIL DC CORE PLUS | Kuraray America, Inc. | 2011-11-17 | 128 | 0 |
| K111980 | CLEARFIL TRI-S BOND PLUS | Kuraray America, Inc. | 2011-10-14 | 94 | 0 |
| K063595 | CLEARFIL MAJESTY POSTERIOR | Kuraray America, Inc. | 2007-02-09 | 67 | 0 |
| K063593 | CLEARFIL MAJESTY FLOW | Kuraray America, Inc. | 2007-02-02 | 60 | 0 |
| K063228 | SURFACE COAT | Kuraray America, Inc. | 2006-12-08 | 44 | 0 |
| K002322 | MODIFICATION TO PANAVIA F | Kuraray America, Inc. | 2000-09-18 | 49 | 0 |
| K983361 | PANAVIA F | Kuraray America, Inc. | 1998-11-13 | 50 | 0 |
| K982259 | CHROMA ZONE COLOR STAIN | Kuraray America, Inc. | 1998-09-22 | 88 | 0 |
| K982164 | ESTENIA | Kuraray America, Inc. | 1998-08-10 | 52 | 0 |
| K974486 | CLEARFIL LINER BOND 2V | Kuraray America, Inc. | 1998-01-29 | 64 | 0 |
| K974089 | ALLOY PRIMER | Kuraray America, Inc. | 1997-12-17 | 49 | 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