FDA 510(k) Applications Submitted by Kuraray Noritake Dental Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K131534 05/29/2013 KATANA ZIRCONIA KURARAY NORITAKE DENTAL INC.
K121980 07/06/2012 ZIRPRIME KURARAY NORITAKE DENTAL INC.
K121583 05/30/2012 CLEARFIL MAJESTY FLOW KURARAY NORITAKE DENTAL INC.
K130371 02/14/2013 CLEARFIL MAJESTY ES FLOW KURARAY NORITAKE DENTAL INC.
K150703 03/18/2015 CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) KURARAY NORITAKE DENTAL INC.
K131068 04/17/2013 TEETHMATE DESENSITIZER SET; TEETHMATE DESENSITIZER POWDER; TEETHMATE DESENSITIZER LIQUID KURARAY NORITAKE DENTAL INC.
K131430 05/17/2013 CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL KURARAY NORITAKE DENTAL INC.
K131432 05/17/2013 CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL KURARAY NORITAKE DENTAL INC.
K132450 08/06/2013 CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND KURARAY NORITAKE DENTAL INC.
K122421 08/09/2012 TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID KURARAY NORITAKE DENTAL INC.
K142625 09/16/2014 PANAVIA SA Cement Plus Automix; (Universal(A2), White, Translucent); Value Pack (Universal(A2), Translucent); Automix Trial (Universal(A2), White, Translucent); Mixing tip; Endo tip (SS) KURARAY NORITAKE DENTAL INC.
K133078 09/27/2013 K-ETCHANT SYRINGE; NEEDLE TIP (E) KURARAY NORITAKE DENTAL INC.
K133211 10/18/2013 ZIRTOUGH KURARAY NORITAKE DENTAL INC.
K220369 02/08/2022 Esthetic Colorant Kuraray Noritake Dental Inc.
K190436 02/22/2019 KATANA Zirconia Block Kuraray Noritake Dental Inc.
K210504 02/22/2021 PANAVIA Veneer LC Kuraray Noritake Dental Inc.
K170834 03/20/2017 CERABIEN ZR Kuraray Noritake Dental Inc.
K170986 04/03/2017 KATANA Zirconia Block Kuraray Noritake Dental Inc.
K191133 04/29/2019 KATANA Cleaner, KATANA Cleaner (Trial) Kuraray Noritake Dental Inc.
K191980 07/24/2019 CLEARFIL MAJESTY ES Flow Kuraray Noritake Dental Inc.
K182430 09/06/2018 CLEARFIL MAJESTY IC Kuraray Noritake Dental Inc.
K213147 09/27/2021 CERABIEN MiLai Kuraray Noritake Dental Inc.
K193060 11/01/2019 Noritake Super Porcelain EX-3 Kuraray Noritake Dental Inc.
K183537 12/19/2018 PANAVIA SA Cement Universal Kuraray Noritake Dental Inc.


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