Kuraray Noritake Dental Kurashiki Plant

FDA Filings

This page includes the latest FDA filings for Kuraray Noritake Dental Kurashiki Plant. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9611259
• FEI Number: 3002807420
• Name: KURARAY NORITAKE DENTAL KURASHIKI PLANT
• Owner & Operator: KURARAY NORITAKE DENTAL INC.
• Contact Address: 1621 SAKAZU ; KURASHIKI JP-33 Okayama 710-0801 JP
• Official Correspondent:
  • KIYOYUKI - ARIKAWA
  • 81-3-67011736-x
• US Agent:
  • MANABU SUZUKI
  • KURARAY AMERICA, INC.
  • 212 3563940
  • 888 7005200
  • manabu.suzuki@kuraray.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1621 SAKAZU ; KURASHIKI Okayama, 710-0801 JP
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K142623 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	PANAVIA SA Cement Plus Handmix	2015-02-26
PMN K142625 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	PANAVIA SA Cement Plus Automix	2015-01-27
PMN K142625 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	KATANA Bonding Kit	2015-01-27
PMN K133078 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	K-ETCHANT Syringe	2014-01-07
PMN K132450 | LBH KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL Universal Bond	2013-11-08
PMN K132450 | LBH KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL Universal Bond Kit	2013-11-08
PMN K132450 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL Universal Bond	2013-11-08
PMN K132450 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL Universal Bond Kit	2013-11-08
PMN K131430 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL DC Activator	2013-09-08
PMN K131068 | EJK KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	TEETHMATE DESENSITIZER	2013-08-30
PMN K131432 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SE BOND 2	2013-08-27
PMN K131432 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SE BOND 2	2013-08-27
PMN K131432 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SE BOND 2	2013-08-27
PMN K130371 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY ES Flow	2013-04-11
PMN K121583 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY ES-2	2012-08-05
PMN K120379 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	PANAVIA SA CEMENT Automix	2012-04-11
PMN K120378 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	PANAVIA SA CEMENT Handmix	2012-04-11
PMN K111982 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL DC CORE PLUS	2011-11-20
PMN K111980 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL TRI-S BOND PLUS	2011-10-19
PMN K111975 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL TRI-S BOND PLUS Unit Dose	2011-10-19
PMN K111975 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL TRI-S BOND PLUS Single Dose	2011-10-19
PMN K100328 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY Posterior	2010-03-08
PMN K092281 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY Posterior PLT	2009-10-29
OFW KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY Starter Kit	2009-10-20
EID KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL DISPENSER	2009-02-03
PMN K070325 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY Esthetic PLT	2008-10-31
PMN K063593 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY Flow	2008-10-31
PMN K062410 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARIFL ESTHETIC CEMENT EX Standard Kit	2008-10-31
PMN K062410 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL ESTHETIC CEMENT EX	2008-10-31
PMN K062410 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL ESTHETIC CEMENT EX Mini Kit	2008-10-31
PMN K062409 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	K-ETCHANT GEL	2008-10-31
PMN K062382 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL DC BOND	2008-10-31
PMN K061906 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL REPAIR Multi Purpose	2008-10-31
PMN K061906 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL CERAMIC PRIMER	2008-10-31
PMN K061860 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL MAJESTY Esthetic	2008-10-31
PMN K033970 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL PHOTO CORE PLT	2008-10-31
PMN K033938 | LBH KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SE Protect	2008-10-31
PMN K033938 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SE Protect	2008-10-31
PMN K032455 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	PANAVIA F 2.0	2008-10-31
PMN K032455 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	PANAVIA F 2.0 Complete Kit	2008-10-31
PMN K023002 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL AP-X PLT	2008-10-31
PMN K021427 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SA PRIMER	2008-10-31
PMN K012742 | EBC KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	TEETHMATE F-1	2008-10-31
PMN K012740 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL AP-X	2008-10-31
PMN K012734 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL NEW BOND	2008-10-31
PMN K012733 | LFC KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CARIES DETECTOR	2008-10-31
PMN K012730 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL PORCELAIN BOND ACTIVATOR	2008-10-31
PMN K012705 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL PHOTO CORE	2008-10-31
PMN K012704 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL ST OPAQUER	2008-10-31
PMN K012703 | EBF KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL CORE NEW BOND	2008-10-31
PMN K012442 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SE BOND	2008-10-31
PMN K012442 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL SE BOND Restorative Kit	2008-10-31
PMN K012440 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL LINER BOND 2V	2008-10-31
PMN K012438 | EMA KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	PANAVIA 21	2008-10-31
PMN K012436 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	ALLOY PRIMER	2008-10-31
PMN K012432 | KLE KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	CLEARFIL PHOTO BOND	2008-10-31
PMN K063228 | EBD KURARAY NORITAKE DENTAL KURASHIKI PLANT [KURARAY NORITAKE DENTAL INC.]	SURFACE COAT	2007-01-18