Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002807420

FEI Number

3002807420

Entity Name

KURARAY NORITAKE DENTAL NIIGATA PLANT

City/State/Country

TAINAI Niigata, JP

Establishment Address

2-28 KURASHIKI-CHO, TAINAI Niigata 959-2653, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

KURARAY NORITAKE DENTAL INC. (Owner Number: 8030414)

Owner / Operator Contact Address

1621 SAKAZU, KURASHIKI, JP-33 710-0801, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K131430

PMA Number

N/A

All Registered Proprietary Names

CLEARFIL PHOTO CORE PLT CLEARFIL SA PRIMER PANAVIA SA Cement Universal PANAVIA 21 CLEARFIL MAJESTY ES Flow CLEARFIL MAJESTY ES Flow Universal CLEARFIL Universal Bond Quick KATANA Cleaner CLEARFIL PHOTO BOND CLEARFIL LINER BOND 2V CLEARFIL MAJESTY Posterior CLEARFIL CERAMIC PRIMER PLUS CLEARFIL MAJESTY ES-2 PANAVIA V5 CLEARFIL DC CORE PLUS CARIES DETECTOR CLEARFIL TRI-S BOND PLUS CLEARFIL PORCELAIN BOND ACTIVATOR CLEARFIL SE Protect Applicator brush (endo) Disposable brush tips (white) Applicator brush (superfine) Applicator brush (fine) Disposable brush tips (black) ALLOY PRIMER K-ETCHANT Syringe CLEARFIL PHOTO CORE CLEARFIL AP-X PLT CLEARFIL DC CORE PLUS Guide tip (S) PANAVIA V5 Mixing tip PANAVIA SA Cement Universal Automix Mixing tip CLEARFIL DC CORE PLUS Mixing tip PANAVIA V5 Endo tip (S) PANAVIA SA Cement Universal Automix Endo tip (SS) CLEARFIL DC CORE PLUS Guide tip (L) CLEARFIL MAJESTY Flow CLEARFIL SE BOND CLEARFIL SE BOND Restorative Kit CLEARFIL ST OPAQUER TEETHMATE DESENSITIZER PANAVIA Veneer LC PANAVIA F 2 PANAVIA F 2 Complete Kit CLEARFIL DC Activator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2019-05-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-05-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-11-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2016-11-07
PME	External Cleaning Solution	Dental	Class 2	872.3260	2019-10-18
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2019-10-18
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2010-03-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2015-08-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-08-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2015-08-23
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-11-20
LFC	Device, Caries Detection	Dental	Class 2	872.1740	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2011-10-19
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-10-31
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-10-31
KXR	Applicator, Resin	Dental	Class 1	872.3140	2024-08-22
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2014-01-07
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-10-31
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2009-02-03
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-10-31
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-10-31
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2013-08-30
EMA	Cement, Dental	Dental	Class 2	872.3275	2021-06-14
EMA	Cement, Dental	Dental	Class 2	872.3275	2008-10-31
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2013-09-08

Official Correspondent

Satoshi Yamaguchi

US Agent Details

MANABU SUZUKI Business: KURARAY AMERICA, INC. Email: manabu.suzuki@kuraray.com Phone: (212) 3563940

Related Public Records

Same Entity

KURARAY NORITAKE DENTAL INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9614705	KURARAY NORITAKE DENTAL INC. MIYOSHI PLANT	MIYOSHI Aichi, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807420. Last updated year: 2026. Please use registration number 3002807420 when referencing this establishment in official correspondence.