FDA 510(k) Applications Submitted by Michio Takigawa

FDA 510(k) Number Submission Date Device Name Applicant
K120378 02/07/2012 PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL INC.
K120379 02/07/2012 PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL 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.
K150704 03/18/2015 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 Pa KURARAY NORITAKE DENTAL, INC.
K161042 04/13/2016 CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack 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.
K111975 07/12/2011 CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK KURARAY MEDICAL 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.
K142623 09/16/2014 PANAVIA SA Cement Plus Handmix 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.
K143439 12/02/2014 KATANA Zirconia KURARAY NORITAKE DENTAL, INC.
K153476 12/02/2015 KATANA AVENCIA Block Kuraray Noritake Dental, Inc.


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