Kuraray America, Inc.
New York, NY, US
KURARAY AMERICA, INC. appears in FDA device records in New York, NY. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Kuraray America, Inc. between 1997 and 2011. The busiest year on record is 1998, with 4. The most recent is 2011, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 1998 | 4 |
| 2000 | 1 |
| 2006 | 1 |
| 2007 | 2 |
| 2011 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111982 | CLEARFIL DC CORE PLUS | EBF | Substantially Equivalent | |
| K111980 | CLEARFIL TRI-S BOND PLUS | KLE | Substantially Equivalent | |
| K063595 | CLEARFIL MAJESTY POSTERIOR | EBF | Substantially Equivalent | |
| K063593 | CLEARFIL MAJESTY FLOW | EBF | Substantially Equivalent | |
| K063228 | SURFACE COAT | EBD | Substantially Equivalent | |
| K002322 | MODIFICATION TO PANAVIA F | EMA | Substantially Equivalent | |
| K983361 | PANAVIA F | EMA | Substantially Equivalent | |
| K982259 | CHROMA ZONE COLOR STAIN | EBF | Substantially Equivalent | |
| K982164 | ESTENIA | EBF | Substantially Equivalent | |
| K974486 | CLEARFIL LINER BOND 2V | KLE | Substantially Equivalent | |
| K974089 | ALLOY PRIMER | KLE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2438248 | 3002675355 | KURARAY AMERICA, INC. | 32 Old Slip, NEW YORK, NY 10005 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain