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TAKARA BELMONT CORPORATION

Japan · Osaka

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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

6listed device types

Class I 4Class II 2Class III 0

plus 11 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

6active device licences

Class II 6

9 including historic records

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

9device registrations

CLASS B 6CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

5active ARTG entries

Class I 2IIa 1IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 1

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 States11 registration records, 14 510(k), 0 PMA, 3 excluded

Brazil1 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: TAKARA BELMONT CORPORATION, OSAKA FACTORY · TAKARA BELMONT CORPORATION · TAKARA BELMONT CORPORATION,SHIGA EQUIPMENT FACTORY · Takara Belmont Corporation

FDA 510(k) clearances by year

32004

12006

22007

12009

12010

32011

12014

12016

12017

FDA listed device types

Chair, Surgical, Ac-Powered 1Unit, Operative Dental, Accessories 1Light, Operating, Dental 1Chair, Dental, Without Operative Unit 1System, X-Ray, Extraoral Source, Digital 1Unit, X-Ray, Extraoral With Timer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163175	Bel-Cypher Pro	2017-03-20
US	K152100	Evogue Dental Unit	2016-01-22
US	K141293	PHOT-X IIS MODEL 505	2014-09-03
BR	81150240001	Cadeira Odontológica Clesta	Class I
CA	66034	DENTAL X-RAY MODEL 096	Class II
CA	77417	X-CALIBUR DENTAL UNIT	Class II
CA	77889	QUOLIS5000 DENTAL DELIVERY SYSTEM	Class II

TAKARA BELMONT 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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