# Kuraray Noritake Dental, Inc.

- Location (FDA's records): Chiyoda-Ku, JP
- FDA decisions: 32 (2012–2025): 32 510(k) clearances
- Product codes: EIH (11), KLE (7), EBF (5), EMA (5), EJK (2), NHA (1), PME (1)
- 510(k) review time since 2016: median 182 days, against 149 for FDA's reviews in the same codes and years (5 of 15 faster)
- Predicates its devices cite: 51 (11 its own); citations of its devices by later devices: 21 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kuraray Medical, Inc.: 23 (https://510kreport.com/company/kuraray-medical)
- Kuraray America, Inc.: 6 (https://510kreport.com/company/kuraray-america)
- Noritake Co., Inc.: 2 (https://510kreport.com/company/noritake)
- Kerr Corporation: 1 (https://510kreport.com/company/kerr)
- Phoenix Dental, Inc.: 1 (https://510kreport.com/company/phoenix-dental)
- Kuraray Medical Kurashiki Plant: 1 (https://510kreport.com/company/kuraray-medical-kurashiki-plant)
- Zirkonzahn Srl: 1 (https://510kreport.com/company/zirkonzahn)
- Shofu Dental Corp.: 1 (https://510kreport.com/company/shofu-dental)

## Firms that cite its devices most
- Kettenbach GmbH & Co. KG: 2 (https://510kreport.com/company/kettenbach)
- Imicryl Dis Malzemeleri Sanayi VE Ticaret AS: 1 (https://510kreport.com/company/imicryl-dis-malzemeleri-sanayi-ve-ticaret)
- Parkell, Inc.: 1 (https://510kreport.com/company/parkell)
- 3M Deutschland GmbH: 1 (https://510kreport.com/company/3m-deutschland)
- Swissmeditec GmbH: 1 (https://510kreport.com/company/swissmeditec)
- S&C Polymer Silicon- Und Composite Spezialitaten GmbH: 1 (https://510kreport.com/company/s-c-polymer-silicon-und-composite-spezialitaten)
- Prevest Denpro Limited: 1 (https://510kreport.com/company/prevest-denpro)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)

## Its most-cited devices
- K121583: Clearfil Majesty Flow (2012), cited by 3
- 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 (2015), cited by 2
- K142625: 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) (2015), cited by 2
- K150703: CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) (2015), cited by 2
- K170834: Cerabien ZR (2017), cited by 1
- K131432: Clearfil SE Bond 2 Kit; Clearfil SE Bond 2 Value Pack; Clearfil SE Bond 2 Trial Pack; Clearfil SE Bond 2 Bond; Clearfil (2013), cited by 1

## Recent decisions
- K250673: CERABIEN MiLai (May 29, 2025)
- K233285: KATANA Zirconia ONE For IMPLANT (May 24, 2024)
- K231039: CLEARFIL Universal Bond Quick 2 (Dec 13, 2023)
- K220369: Esthetic Colorant (Sep 23, 2022)
- K213147: CERABIEN MiLai (Mar 28, 2022)
- K210504: PANAVIA Veneer LC (Jun 11, 2021)
- K193060: Noritake Super Porcelain EX-3 (Jan 30, 2020)
- K191980: CLEARFIL MAJESTY ES Flow (Nov 18, 2019)

Source page: https://510kreport.com/company/kuraray-noritake-dental