Data / Medical devices / Japan / Kuraray Noritake Dental Niigata Plant
Kuraray Noritake Dental Niigata Plant: FDA-registered device maker in TAINAI Niigata, Japan, 36 510(k) clearances
Kuraray Noritake Dental Niigata Plant is registered with the FDA (registration 3002807420) in TAINAI Niigata, Japan. It lists 9 device types. The FDA files 36 510(k) clearances under its listings, the newest dated December 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002807420
- Address
- 2-28 Kurashiki-Cho, TAINAI Niigata, Japan, 959-2653
- Owner or operator
- KURARAY NORITAKE DENTAL INC. (8030414)
- Roles
- Manufacturer
- First device listed
- October 31, 2008
- Registered through
- 2026
- Brand names listed
- ALLOY PRIMER, Applicator brush (endo<black>), Applicator brush (fine<silver>), Applicator brush (superfine<white>), CARIES DETECTOR, CLEARFIL AP-X, CLEARFIL AP-X PLT, CLEARFIL CERAMIC PRIMER PLUS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Device, Caries Detection | LFC | 2 | Manufacturer | accessdata.fda.gov |
| External Cleaning Solution | PME | 2 | Manufacturer | accessdata.fda.gov |
| Liner, Cavity, Calcium Hydroxide | EJK | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 13, 2023 | K231039 | CLEARFIL Universal Bond Quick 2 | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| June 11, 2021 | K210504 | PANAVIA Veneer LC | EMA | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| November 18, 2019 | K191980 | CLEARFIL MAJESTY ES Flow | EBF | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| October 8, 2019 | K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | PME | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| May 3, 2019 | K182430 | CLEARFIL MAJESTY IC | EBF | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| April 25, 2019 | K183537 | PANAVIA SA Cement Universal | EMA | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| October 25, 2016 | K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| August 21, 2015 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer | EMA | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| August 13, 2015 | K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| December 20, 2013 | K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| November 1, 2013 | K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| August 27, 2013 | K131068 | TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID | EJK | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| August 22, 2013 | K131432 | CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL | KLE | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| July 25, 2012 | K121583 | CLEARFIL MAJESTY FLOW | EBF | Substantially Equivalent | Kuraray Noritake Dental, Inc. | accessdata.fda.gov |
| November 17, 2011 | K111982 | CLEARFIL DC CORE PLUS | EBF | Substantially Equivalent | Kuraray America, Inc. | accessdata.fda.gov |
| October 14, 2011 | K111980 | CLEARFIL TRI-S BOND PLUS | KLE | Substantially Equivalent | Kuraray America, Inc. | accessdata.fda.gov |
| March 5, 2010 | K100328 | CLEARFIL MAJETY POSTERIOR | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| October 27, 2009 | K092281 | CLEARFIL MAJESTY POSTERIOR PLT | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| February 2, 2007 | K063593 | CLEARFIL MAJESTY FLOW | EBF | Substantially Equivalent | Kuraray America, Inc. | accessdata.fda.gov |
| November 8, 2006 | K062409 | K-ETCHANT GEL | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| March 26, 2004 | K033970 | CLEARFIL PHOTO CORE PLT | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| January 29, 2004 | K033938 | CLEARFIL PROTECT BOND | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| November 7, 2003 | K032455 | PANAVIA F 2.0 | EMA | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| October 25, 2002 | K023002 | CLEARFIL AP-X PLT | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| June 7, 2002 | K021427 | CLEARFIL SA PRIMER | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 14, 2001 | K012740 | CLEARFIL AP-X | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 14, 2001 | K012733 | CARIES DETECTOR | LFC | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 13, 2001 | K012730 | CLEARFIL PORCELAIN BOND ACTIVATOR | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 11, 2001 | K012705 | CLEARFIL PHOTO CORE | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 10, 2001 | K012704 | CLEARFIL ST OPAQUER | EBF | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 10, 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 5, 2001 | K012440 | MODIFICATION TO CLEARFIL LINER BOND 2V | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 5, 2001 | K012438 | MODIFICATION TO PANAVIA 21 | EMA | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 4, 2001 | K012436 | MODIFICATION TO ALLOY PRIMER | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
| September 4, 2001 | K012432 | MODIFICATION TO CLEARFIL PHOTO BOND | KLE | Substantially Equivalent | Kuraray Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Tooth Bonding, Resin
- All makers of Material, Tooth Shade, Resin
- All makers of Cement, Dental
- All makers of Applicator, Resin
- All makers of Syringe, Restorative And Impression Material
- All makers of Liner, Cavity, Calcium Hydroxide
Updated December 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.