Kuraray Medical, Inc.
New York, NY, US
Kuraray Medical, Inc. appears in FDA device records in New York, NY. FDA records list 42 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 42
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 42 510(k) clearances for Kuraray Medical, Inc. between 2001 and 2012. The busiest year on record is 2001, with 18. The most recent is 2012, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 18 |
| 2002 | 3 |
| 2003 | 4 |
| 2004 | 4 |
| 2006 | 5 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA | Substantially Equivalent | |
| K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S | EMA | Substantially Equivalent | |
| K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK | KLE | Substantially Equivalent | |
| K100328 | CLEARFIL MAJETY POSTERIOR | EBF | Substantially Equivalent | |
| K092281 | CLEARFIL MAJESTY POSTERIOR PLT | EBF | Substantially Equivalent | |
| K081583 | CLEARFIL SA CEMENT | EMA | Substantially Equivalent | |
| K071169 | CLEARFIL MAJESTY POSTERIOR PLT | EBF | Substantially Equivalent | |
| K070325 | CLEARFIL MAJESTY ESTHETIC PLT | EBF | Substantially Equivalent | |
| K062409 | K-ETCHANT GEL | EBF | Substantially Equivalent | |
| K061906 | CLEARFIL CERAMIC PRIMER | EBF | Substantially Equivalent | |
| K062382 | CLEARFIL DC BOND | KLE | Substantially Equivalent | |
| K062410 | CLEARFIL ESTHETIC CEMENT & DC BOND | EMA | Substantially Equivalent | |
| K061860 | CLEARFIL MAJESTY ESTHETIC | EBF | Substantially Equivalent | |
| K043177 | CLEAFIL DC CORE AUTOMIX | EBF | Substantially Equivalent | |
| K042913 | CLEARFIL TRI-S BOND | KLE | Substantially Equivalent | |
| K033970 | CLEARFIL PHOTO CORE PLT | EBF | Substantially Equivalent | |
| K033938 | CLEARFIL PROTECT BOND | KLE | Substantially Equivalent | |
| K033267 | EPRICORD | EBF | Substantially Equivalent | |
| K032455 | PANAVIA F 2.0 | EMA | Substantially Equivalent | |
| K024356 | CLEARFIL SILANE KIT | KLE | Substantially Equivalent | |
| K023842 | CLEARFIL SE BOND PLUS | KLE | Substantially Equivalent | |
| K023002 | CLEARFIL AP-X PLT | EBF | Substantially Equivalent | |
| K022999 | CLEARFIL AP-X PLT INTRO KIT | EBF | Substantially Equivalent | |
| K021427 | CLEARFIL SA PRIMER | KLE | Substantially Equivalent | |
| K012742 | TEETHMATE F-1 | EBC | Substantially Equivalent | |
| K012740 | CLEARFIL AP-X | EBF | Substantially Equivalent | |
| K012737 | CHROMA ZONE COLOR STAIN | EBF | Substantially Equivalent | |
| K012735 | CLEARFIL DC CEMENT | EMA | Substantially Equivalent | |
| K012734 | CLEARFIL NEW BOND | KLE | Substantially Equivalent | |
| K012733 | CARIES DETECTOR | LFC | Substantially Equivalent | |
| K012730 | CLEARFIL PORCELAIN BOND ACTIVATOR | KLE | Substantially Equivalent | |
| K012729 | CLEARFIL REPAIR | KLE | Substantially Equivalent | |
| K012707 | ESTENIA | EBF | Substantially Equivalent | |
| K012705 | CLEARFIL PHOTO CORE | EBF | Substantially Equivalent | |
| K012704 | CLEARFIL ST OPAQUER | EBF | Substantially Equivalent | |
| K012703 | CLEARFIL CORE NEW BOND | EBF | Substantially Equivalent | |
| K012442 | MODIFICATION TO CLEARFIL SE BOND | KLE | Substantially Equivalent | |
| K012441 | PANAVIA F | EMA | Substantially Equivalent | |
| K012440 | MODIFICATION TO CLEARFIL LINER BOND 2V | KLE | Substantially Equivalent | |
| K012438 | MODIFICATION TO PANAVIA 21 | EMA | Substantially Equivalent | |
| K012436 | MODIFICATION TO ALLOY PRIMER | KLE | Substantially Equivalent | |
| K012432 | MODIFICATION TO CLEARFIL PHOTO BOND | KLE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
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