Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of KurarayLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Kuraray America with 11 510(k) clearances. The most recent is a 510(k) clearance dated Nov 17, 2011: CLEARFIL DC CORE PLUS.
| Nov 17, 2011 | CLEARFIL DC CORE PLUSK111982 · EBF | 510(k) clearances |
| Oct 14, 2011 | CLEARFIL TRI-S BOND PLUSK111980 · KLE | 510(k) clearances |
| Feb 9, 2007 | CLEARFIL MAJESTY POSTERIORK063595 · EBF | 510(k) clearances |
| Feb 2, 2007 | CLEARFIL MAJESTY FLOWK063593 · EBF | 510(k) clearances |
| Dec 8, 2006 | SURFACE COATK063228 · EBD | 510(k) clearances |
| Sep 18, 2000 | MODIFICATION TO PANAVIA FK002322 · EMA | 510(k) clearances |
| Nov 13, 1998 | PANAVIA FK983361 · EMA | 510(k) clearances |
| Sep 22, 1998 | CHROMA ZONE COLOR STAINK982259 · EBF | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
