Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003621174

FEI Number

3003621174

Entity Name

TOKUYAMA DENTAL CORPORATION Kashima Factory

City/State/Country

Kamisu-shi Ibaraki, JP

Establishment Address

26, Sunayama, Kamisu-shi Ibaraki 314-0255, JP

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TOKUYAMA DENTAL CORPORATION (Owner Number: 9000502)

Owner / Operator Contact Address

38-9 Taitou 1-chome, Taitou-ku, JP-13 110-0016, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K080940

PMA Number

N/A

All Registered Proprietary Names

Cement Mixing Tip Nozzle for Mini Mixing Tip TD II Dispenser Palfique Estelite LV Syringe Tip TD II Mixing Tip Disposable Applicator Tip and Handle Mini Mixing Tip S Tokuyama Plastic Tip Tokuyama Dispensing Tip TOKUYAMA UNIVERSAL BOND II Sofreliner Tough S TOKUYAMA REBASE III Tokuyama Universal Bond Estelite Color OMNICHROMA BLOCKER FLOW Estelite Universal Flow Tokuyama One-Up Bond F One-Up Bond F Plus Estelite Sigma Introductory Kit Estelite Bulk Fill Flow E-1 Esthetic Composite System Estelite Omega OMNICHROMA FLOW Tokuso Rebase Mr. Bond OMNICHROMA ESTECEM ESTECEM II OMNICHROMA FLOW BULK Brush No. 24 Palfique LX5 Estelite Sigma Quick OMNICHROMA BLOCKER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2003-03-14
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2021-06-08
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2011-11-08
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2019-10-19
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2017-12-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2011-04-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-07-16
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-03-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2017-04-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-20
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2020-08-20
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2008-03-05
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-03-07
EMA	Cement, Dental	Dental	Class 2	872.3275	2015-06-18
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2021-02-10
KXR	Applicator, Resin	Dental	Class 1	872.3140	2011-04-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-06-20

Official Correspondent

No official correspondent registered.

US Agent Details

Keith Barritt Business: Fish & Richardson P.C. Email: barritt@fr.com Phone: (202) 6266433

Related Public Records

Same Entity

TOKUYAMA DENTAL CORPORATION

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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.).

Similar Registrations

Registration Number	Establishment Name	Location
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3003169405	MONITEX INDUSTRIAL CO., LTD.	SAN-CHUNG CITY Taipei, TW
3012041047	JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD	Jiujiang City Jiangxi, CN
9680845	SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, MX
3008770655	BEYES DENTAL INC	Toronto Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003621174. Last updated year: 2026. Please use registration number 3003621174 when referencing this establishment in official correspondence.