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Tokuyama Dental Corporation

Japan · Tokyo

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, Russia — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 2Class II 5Class III 0

plus 20 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class II 12

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

16active device licences

Class II 3Class III 13

35 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

9active ARTG entries

Class I 5IIa 4

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

17active registrations

Class 2a 17

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States20 registration records, 19 510(k), 0 PMA, 2 excluded

Brazil12 confirmed, 0 excluded

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: TOKUYAMA DENTAL CORPORATION Kashima Factory · TOKUYAMA DENTAL CORPORATION

FDA 510(k) clearances by year

12003

12005

22007

12008

12009

12010

22011

12015

32017

22018

12019

12020

22021

FDA listed device types

Applicator, Resin 1Syringe, Restorative And Impression Material 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Varnish, Cavity 1Material, Tooth Shade, Resin 1Agent, Tooth Bonding, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K203760	Tokuyama Universal Bond II	2021-05-25
US	K203598	Omnichroma Flow Bulk	2021-02-03
US	K193537	Omnichroma Flow	2020-08-19
BR	81199279032	ESTECEM Plus	Class II
BR	80352500003	Resinas ESTELITE	Class II
BR	80352500006	BOND FORCE	Class II
CA	76	TOKUYAMA SOFRELINER SILICONE-BASED SOFT DENTURE LINER	Class II
CA	4932	TOKUYAMA SOFT RELINING	Class III
CA	4936	TOKUYAMA SOFRELINER SILICONE-BASED SOFT DENTURE LINER	Class II

Tokuyama Dental Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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