Medical Device Manufacturer · US , New York , NY

Kuraray Noritake Dental, Inc.

32 submissions · 32 cleared · Since 2012
32
Total
32
Cleared
0
Denied

Kuraray Noritake Dental, Inc. — FDA 510(k) Submissions

Kuraray Noritake Dental, Inc. has submitted 32 FDA 510(k) premarket notifications since 2012, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powder, Porcelain, Agent, Tooth Bonding, Resin, Material, Tooth Shade, Resin, Cement, Dental, Liner, Cavity, Calcium Hydroxide . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
CERABIEN MiLai
K250673 · EIH Powder, Porcelain · Dental
May 2025 84d
KATANA Zirconia ONE For IMPLANT
K233285 · NHA Abutment, Implant,... · Dental
May 2024 238d
CLEARFIL Universal Bond Quick 2
K231039 · KLE Agent, Tooth Bonding, Resin · Dental
Dec 2023 245d
Esthetic Colorant
K220369 · EIH Powder, Porcelain · Dental
Sep 2022 227d
CERABIEN MiLai
K213147 · EIH Powder, Porcelain · Dental
Mar 2022 182d
PANAVIA Veneer LC
K210504 · EMA Cement, Dental · Dental
Jun 2021 109d
Noritake Super Porcelain EX-3
K193060 · EIH Powder, Porcelain · Dental
Jan 2020 90d
CLEARFIL MAJESTY ES Flow
K191980 · EBF Material, Tooth Shade, Resin · Dental
Nov 2019 117d
KATANA Cleaner, KATANA Cleaner (Trial)
K191133 · PME External Cleaning Solution · Dental
Oct 2019 162d
KATANA Zirconia Block
K190436 · EIH Powder, Porcelain · Dental
May 2019 90d
CLEARFIL MAJESTY IC
K182430 · EBF Material, Tooth Shade, Resin · Dental
May 2019 239d
PANAVIA SA Cement Universal
K183537 · EMA Cement, Dental · Dental
Apr 2019 127d
CERABIEN ZR
K170834 · EIH Powder, Porcelain · Dental
Oct 2017 211d
KATANA Zirconia Block
K170986 · EIH Powder, Porcelain · Dental
Jul 2017 101d
CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack
K161042 · KLE Agent, Tooth Bonding, Resin · Dental
Oct 2016 195d
KATANA AVENCIA Block
K153476 · EBF Material, Tooth Shade, Resin · Dental
Aug 2016 265d
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
K150704 · EMA Cement, Dental · Dental
Aug 2015 156d
CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)
K150703 · KLE Agent, Tooth Bonding, Resin · Dental
Aug 2015 148d
KATANA Zirconia
K143439 · EIH Powder, Porcelain · Dental
Feb 2015 87d
PANAVIA SA Cement Plus Handmix
K142623 · EMA Cement, Dental · Dental
Feb 2015 163d
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)
K142625 · EMA Cement, Dental · Dental
Jan 2015 133d
ZIRTOUGH
K133211 · EIH Powder, Porcelain · Dental
Mar 2014 153d
K-ETCHANT SYRINGE; NEEDLE TIP (E)
K133078 · KLE Agent, Tooth Bonding, Resin · Dental
Dec 2013 84d
CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND
K132450 · KLE Agent, Tooth Bonding, Resin · Dental
Nov 2013 87d
KATANA ZIRCONIA
K131534 · EIH Powder, Porcelain · Dental
Oct 2013 135d
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