Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kuraray Company, Ltd. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
40 daysmedian FDA review time
98 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001914 | CLEARFIL REPAIR | Kuraray Company, Ltd. | 2000-08-10 | 48 | 0 |
| K001913 | CLEARFIL ST OPAQUER | Kuraray Company, Ltd. | 2000-08-04 | 42 | 0 |
| K980232 | CLEARFIL DC CEMENT | Kuraray Company, Ltd. | 1998-02-24 | 33 | 0 |
| K965091 | TEETHMATE F-1 | Kuraray Company, Ltd. | 1997-03-27 | 98 | 0 |
| K943168 | CLEARFIL AP-X | Kuraray Company, Ltd. | 1994-08-10 | 40 | 0 |
| K943169 | CLEARFIL AP-X AND LINER BOND 2 | Kuraray Company, Ltd. | 1994-08-10 | 40 | 0 |
| K943167 | CLEARFIL NEW BOND | Kuraray Company, Ltd. | 1994-08-10 | 40 | 0 |
| K943165 | CLEARFIL PHOTO BOND | Kuraray Company, Ltd. | 1994-08-10 | 40 | 0 |
| K943170 | CLEARFIL LINER BOND 2 | Kuraray Company, Ltd. | 1994-08-10 | 40 | 0 |
| K943166 | CLEARFIL LINER BOND SYSTEM | Kuraray Company, Ltd. | 1994-08-10 | 40 | 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